MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 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	07/17/2019
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.(b)(6).Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate via email that during a laparoscopy appendix surgery the tck 1 hd camera head stopped relaying the image or video on to the attached monitor.It turned into a multicolor stripped screen.Additional information received from the affiliate reported a surgical delay of 5 minutes and the need to convert the procedure from an arthroscopic to open procedure.The affiliate reported there were no known patient or user harm and the procedure was completed by converting to an open procedure.It was also reported there were no alternative products available at the time.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: the device was received and evaluated at the service center.The reported complaint about the display issues of the device has been confirmed.It was found that the camera head did not work.The device was deemed not repairable and was replaced with a new one.Given the information provided we cannot discern a definitive root cause for the reported failure.No non-conformances were identified for this part number, lot number combination per qlik query executed on 7/24/2019.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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 SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8911443
• Report Number: 1221934-2019-58058
• Device Sequence Number: 19289986
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/01/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1