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

Model Number	242400
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported by distributor via complaint submission tool that pre-operatively to a knee arthroscopy, a tck1 hd camera head was faulty, camera stopped working and there was no display seen.No surgical delay or patient consequences reported.
Additional 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.H10 additional narrative: d10, h3, h6: 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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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 initia medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated at the service center.The reported complaint that camera head was faulty, camera stopped working and there was no display seen, was confirmed.It was found that the camera head was not working.The device was however deemed non-repairable and was returned without repair to the customer.Given the information provided, we cannot discern a definitive root cause of the reported complaint by the customer.A manufacturing record evaluation was performed for the finished device serial number ((b)(6)), and no non-conformance was identified.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.

• 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: 10416234
• Report Number: 1221934-2020-02238
• Device Sequence Number: 14337214
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2020

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 Model Number: 242400
• Device Catalogue Number: 242400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 11/26/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 11/20/2020; 11/30/2020
• Patient Sequence Number: 1