MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TCK1 HD CAMERA HEAD; ENDOSCOPIC VIDEO CAMERA

Catalog Number	242400
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional 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.Initial reporter phone number: (b)(6).Udi:(b)(4).
Event or Problem Description
It was reported by the affiliate via email that during the surgery by using ovb1 ccu and tck1 hd camera head, the camera stopped giving output on the screen.Additional information received form the affiliate reported that the procedure was cancelled because the camera did not work and an alternative device was not available.
Additional 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.Investigation summary: the complaint device was received and evaluated at the service and repair center.Per service report, the device passed testing administered and functions as intended.No deficiencies were found.Therefore, this complaint cannot be confirmed.No root cause has been determined as the reported failure was not identified.Furthermore, a non-conformance search was performed and no non-conformances were identified for this part-serial number combination.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TCK1 HD CAMERA HEAD
• Common Device Name: ENDOSCOPIC VIDEO CAMERA
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8429718
• Report Number: 1221934-2019-56626
• Device Sequence Number: 16835581
• Product Code: FWF
• UDI-Device Identifier: 10886705026258
• UDI-Public: 10886705026258
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 242400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/30/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention