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

Catalog Number	242400
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received at service center and evaluated.Per service manual operational and diagnostic analysis confirmed reported issue of the image cutting out.The device would intermittently not display video or would display poor quality video.However,the root cause for the reported failure is undetermined.There is no repair authorized for this device, so the device will be placed into long term hold with no further repair activities taking place.Furthermore, no non-conformances were identified for this part number (242400), serial number ((b)(4)) combination.Review conducted per qlik query executed on (b)(6)2019.At this point in time, no corrective action is required, and no further action is warranted.However, 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.(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a shoulder repair procedure the customer's tck1 camera head had poor image quality and the image was cutting out.The case was completed with another like-device with no patient harm or delay.The device is being returned for evaluation.

• 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: 8460252
• Report Number: 1221934-2019-56700
• Device Sequence Number: 11467736
• Product Code: FWF
• UDI-Device Identifier: 10886705026258
• UDI-Public: 10886705026258
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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: 12/17/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/28/2019
• Patient Sequence Number: 1