Vigilance Form

Section 1: Submitters details

Full name *

Job title *

Name of organisation/company *

Email *

Telephone number *

Reference

Are you a Corin employee? *

Yes

Section 2: Complaint information

Name of healthcare facility

Country in which event occurred *

Date event occurred

Unknown?

Event details (please check all that apply)

Please provide a comprehensive event description *

Date of implantation

Date

Not applicable?

Unknown

Date of explantation

Date

Not applicable?

Unknown

Number of devices involved *

As a result of this event was the surgery time extended? *

Yes

Not applicable

Is the item involved in the event still in use? *

Yes

Not applicable

Was a technology used during this surgery? *

Yes

Unknown

Was a technology used during the primary surgery? *

Yes

Unknown

What was the impact to the patient? (Check all that apply) *

Disability or permanent damage

Extended hospitalisation

Frequency of patient monitoring increased

Not involving a patient

Patient(s) recalled for unscheduled check

Revision surgery required

Surgeon reverted to standard operating procedure without use of assistive technology

There was no impact to the patient

Other (please specify)

Section 3: Device information

Product description as labelled *

Part Number *

Lot Code / Serial No. *

UDI ref. if implant

Patient Case ID or First 3 Letters of Patient

Is device available to be returned to Corin? *

Yes

Unknown

Section 4: Associated device information

Product 1

Product description as labelled

Part Number

Lot Code / Serial No.

UDI ref. if implant

Patient Case ID or First 3 Letters of Patient

Is device available to be returned to Corin?

Yes

Unknown

Add device 2

Section 5: Additional information

For revisions resulting from infection or metallosis, please supply and attach all or any of the following; pathology report, surgical report or feedback, histology report, blood test results (e.g. CoCr levels)

For all other revisions, please supply and attach any or all of the following; x-rays (pre and post op), bone scans, CT scans, MRI images, surgical report or feedback.

Attachment 1

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Attachment 2

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Attachment 3

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Attachment 4

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Attachment 5

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Are other relevant documents attached? (e.g. medical notes / usage ticket / log files)

Yes

Would you (and/or the customer) like to be informed of the results of our investigations? *

Section 6: OMNIBotics

Date of Surgery

Hospital

Surgeon Name

List of Parts that have been Returned for Investigation (Including Serial Numbers)

Intra Operative Issue Remediation

Were any components of the system successfully swapped out, allowing the procedure to continue as intended

Yes

Was the surgery able to proceed by modifying the workflow?

Yes

Please describe any troubleshooting that was attempted (examples: Undock-redock laptop, power-cycle/emergency stop control Box, cable unplugging/plugging)

Post Operative Questions

Please provide Corin Connect Case ID (xxx-yyy-12345) (from V2.7)

Have the electronic ‘log’ files been attached (see instructions below)?

Yes

Which Software Version is in use (as shown on system startup page) (v.2.5, v2.6, v2.7.1)

Add log files here

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Click on the link below for a quick tip on downloading the OMNI log files.

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Vigilance Form

Section 1: Submitters details

Section 2: Complaint information

Event details (please check all that apply)

Date of implantation

Date of explantation

Section 3: Device information

Section 4: Associated device information

Product 1

Product 2

Product 3

Product 4

Product 5

Section 5: Additional information

Section 6: OMNIBotics

Intra Operative Issue Remediation

Post Operative Questions

Vigilance Form

Section 1: Submitters details

Section 2: Complaint information

Event details (please check all that apply)

Date of implantation

Date of explantation

Section 3: Device information

Section 4: Associated device information

Product 1

Product 2

Product 3

Product 4

Product 5

Section 5: Additional information

Section 6: OMNIBotics

Intra Operative Issue Remediation

Post Operative Questions

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