MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FIXED FOCAL LENGTH COUPLER 19MM; ENDOSCOPE CAMERA ADAPTOR

Model Number 242437

Device Problems Break (1069); Moisture Damage (1405); Device-Device Incompatibility (2919); Difficult to Open or Close (2921)

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

Event Date 11/17/2022

Event Type  malfunction  

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Reporter is a j&j sales representative.The device manufacture date is currently unavailable.Investigation summary: the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: optical capsule damaged.Per service reports, this complaint cannot be confirmed.The device was scrapped as system is non-repairable.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The user error was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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.Device history review: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.

Event Description

It was reported by the sales rep that during a shoulder repair procedure on (b)(6) 2022, it was observed that the arms on the fixed focal length coupler 19mm device were not closing tightly that water entered the lens.According to the report, the team constantly had to keep drying the scope and spreading the arms manually to hold the scope right.It was further reported that the spring arms appeared to be sticking.During in-house engineering evaluation, it was determined that the optical capsule on the device was damaged.It was unknown how the procedure was completed with a delay of 10 minutes.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: FIXED FOCAL LENGTH COUPLER 19MM
• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16125524
• MDR Text Key: 308103993
• Report Number: 1221934-2023-00179
• Device Sequence Number: 1
• Product Code: FEM
• UDI-Device Identifier: 10886705028610
• UDI-Public: 10886705028610
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242437
• Device Catalogue Number: 242437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1