MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OVB1 CAMERA CONTROL UNIT; ENDOSCOPIC VIDEO IMAGE PROCESSOR

Model Number 242300

Device Problem Intermittent Continuity (1121)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).Udi: (b)(4).

Event Description

It was reported by the affiliate via email that the ovb1 camera control unit in between the surgery, the camera stopped giving output on the screen.Additional information provided by the affiliate reported that the camera control unit stopped working during the procedure.The procedure was cancelled due to this malfunction.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that there was no spare camera available for use during surgery.It was reported that the patient was saying about complaining to the ms (medical superintendent); however, the reporter was not aware of any legal action.It was reported that the surgery rescheduled for next day.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).No nonconformances were identified for this part-lot number combination.Per qlik query executed 03/13/2019.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Correction: d10: the date device returned to manufacturer was inadvertently missed on the previous report.It has been updated accordingly to reflect the correct information.Investigation summary =the complaint device was received at the service center and evaluated.It was reported that the device stopped giving output on the screen.Per service manual operational and diagnostic, this complaint can be confirmed.It was found during evaluation that the device was not working and the isolation board was defective.Since the customer did not approve the repair request, the device was not restored to the specifications.It is being returned to the customer without repair.The defective isolation board would have caused the reported problem.With the available information, we cannot determine how the isolation board became defective.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 11/04/2018 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: OVB1 CAMERA CONTROL UNIT
• Type of Device: ENDOSCOPIC VIDEO IMAGE PROCESSOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8505981
• MDR Text Key: 141662291
• Report Number: 1221934-2019-56790
• Device Sequence Number: 1
• Product Code: FWF
• UDI-Device Identifier: 10886705026180
• UDI-Public: 10886705026180
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242300
• Device Catalogue Number: 242300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Date Manufacturer Received: 09/25/2020
• Patient Sequence Number: 1