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

Model Number 242401

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that while using a camera head ac - c-mount, the picture had red streaks, it seemed to have a short.Per service manual operational and diagnostic, this complaint can be confirmed.It was found during evaluation that the device having poor image quality and intermittent / no video.Further, minor scratches were identified with the device upon decontamination.The device was non-reparable and the service of the device was declined; therefore, the device was not restored to the specifications and was placed into long-term hold as it was not needed for the equipment exchange pool use.The minor scratches on the device is most likely a result of user mishandling, probably during transport or storage of the device.With the available information, we cannot determine the root cause of the main identified failures.The damaged camera head ac - c-mount would have caused the customer to experience the reported problem.A manufacturing record evaluation was performed for the finished device serial number ((b)(4)), 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.

Event Description

It was reported by the sales rep that at the end of an unknown procedure on an unknown date, it was observed that the camera head ac - c-mount device, it was observed that the picture had red streaks; and that it seemed to have a short.During in-house engineering evaluation, it was determined that the device had intermittent operation between the having poor image quality and intermittent / no video.There was no surgical delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: CAMERA HEAD AC - C-MOUNT
• Type of Device: ENDOSCOPIC VIDEO CAMERA
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11065076
• MDR Text Key: 223778290
• Report Number: 1221934-2020-04045
• Device Sequence Number: 1
• Product Code: FWF
• UDI-Device Identifier: 10886705028733
• UDI-Public: 10886705028733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 11/30/2020
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1