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

Model Number 242436

Device Problem Crack (1135)

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

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that there was a crack in the lens was confirmed.According to the evaluation by the manufacturer, the lenses were found to be broken.However the device was returned without repair as the repair price exceeded the purchase price of the device.User mishandling or a probable fall is the root cause of the physical damage to the device as identified during evaluation by the manufacturer.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 02/05/2020 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.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 during a knee arthroscopy procedure on (b)(6) 2021, it was observed that the coupler ac zoom device seemed to have a crack on the lens.During in-house engineering evaluation, it was determined that the device had broken lens.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.

• 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
• 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: 11292635
• MDR Text Key: 230712952
• Report Number: 1221934-2021-00408
• Device Sequence Number: 1
• Product Code: FEM
• UDI-Device Identifier: 10886705028634
• UDI-Public: 10886705028634
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• 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: 02/03/2021
• Date Manufacturer Received: 02/08/2021
• 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