MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CAMERA HEAD AC - C-MOUNT; ENDOSCOPIC VIDEO CAMERA

Model Number 242401

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

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.Udi: (b)(4).

Event Description

It was reported by the sales rep via email that the metal plate was detached from the camera head ac - c-mount.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device is available for evaluation.

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: a manufacturing record evaluation was performed for the finished device [1902ce0906] number, and no non-conformances were identified.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.

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: investigation summary:the complaint device was received at the service center and evaluated.The sales rep reported an issue of the metal plate was detached from the device.Per service manual operational and diagnostic, this complaint can be confirmed.It was found during evaluation that the device was physically broken.Since the device was found to be non-repairable, the repair was declined so the device was not restored to the specifications.It is being placed into long term hold.Multiple attempts were done to obtain more information regarding the event but no response was received.With the available information, we cannot determine the root cause of the reported and identified failures.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 (b)(6) 2020 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: CAMERA HEAD AC - C-MOUNT
• Type of Device: ENDOSCOPIC VIDEO CAMERA
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10370672
• MDR Text Key: 201870908
• Report Number: 1221934-2020-02012
• Device Sequence Number: 1
• Product Code: FWF
• UDI-Device Identifier: 10886705028733
• UDI-Public: 10886705028733
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242401
• Device Catalogue Number: 242401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 09/15/2020
• Patient Sequence Number: 1