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

Model Number 242401

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Not Applicable (3189)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
=
> (b)(4).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.Additional narrative: udi: (b)(4).

Event Description

It was reported by sales rep via email, that during a knee arthroscopy, a camera head ac- c-mount kept flickering like there was a short in it.They used another camera to complete the case.There was a surgical delay of 2 minutes to set up the replacement camera and no patient consequences.

Manufacturer Narrative

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.Additional narrative: 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

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.H10 additional narrative: investigation summary
=
> the complaint device was received at the service center and evaluated.It was reported that during a knee arthroscopy, a camera head ac- c-mount kept flickering like there was a short in it.Per service manual operational and diagnostic, the device was found to be non-repairable, therefore this complaint can be confirmed.During evaluation, the electrical safety test failed.Besides, it was found that the display was defective with intermittent operation.The repair was declined, and it was not restored to the specifications.It is being placed into long term hold.With the given information, we cannot determine the root cause of the reported problem.For the display issue can be attribute to lack maintenance.Also, the electrical test failed could be related as a failure into electrical internal components.A manufacturing record evaluation was performed for the finished device [(b)(4) ] number, and no non-conformances were identified.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 history lot
=
> a manufacturing record evaluation was performed for the finished device [(b)(4) ] number, and no non-conformances were identified.

• 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: 9875974
• MDR Text Key: 187076784
• Report Number: 1221934-2020-00971
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• 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: 03/30/2020
• Date Manufacturer Received: 04/27/2020
• Patient Sequence Number: 1