MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL COUPLER AC ZOOM; ENDOSCOPE CAMERA ADAPTOR

Model Number 242436

Device Problems Display or Visual Feedback Problem (1184); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep that during return inspection, it was observed that the coupler ac zoom device would not focus and had loose debris inside.There was no procedure nor patient involvement reported.No additional information was provided.

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.Investigation summary: the complaint device was received at the service center and evaluated.It was reported that during returning inspection the coupler ac zoom would not focus, it has loose debris inside.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: external damage of adjusting rings , will not focus.Loose lens inside the optical system.Minor scratches on the unit.Due to the fact that the defect is located inside the optical capsule, the coupler is not repairable.Most likely the damage was caused by fall, user error was identified as the root cause for the device failure during the service evaluation.A manufacturing record evaluation was performed for the finished device [b000503] number, and no non-conformances were 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: COUPLER AC ZOOM
• Type of Device: ENDOSCOPE CAMERA ADAPTOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11486068
• MDR Text Key: 245911091
• Report Number: 1221934-2021-00846
• Device Sequence Number: 1
• Product Code: FEM
• UDI-Device Identifier: 10886705028634
• UDI-Public: 10886705028634
• 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
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242436
• Device Catalogue Number: 242436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1