MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL COUPLER AC FFL 22; ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)

Catalog Number	242435
Medical Device Problem Codes	Moisture Damage (1405); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report 4 of 5 for (b)(4).It was reported that during an unspecified surgical procedure, (x2) coupler ac ffl 22 devices had water inside and (x2) coupler ac ffl 22 devices were not holding lens along with a camera head ac - c-mount device.During in-house engineering evaluation, it was determined that the coupler ac ffl 22 device had foreign substance/debris/cleaning/sterilization.The exact date of this event is unknown.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional 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.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.H11 additional narrative: h4: the date of manufacture is unknown at this time.Investigation summary: the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: visual: foreign substance/debris/cleaning/sterilization, device interaction (2+ devices): will not hold/retain.Grasping mechanism defective / worn out.Residues in the optical capsule.Per service reports, this complaint was confirmed.Based on service manual operational and diagnostic, the device was found to be non-repairable, and it was scrapping.Based on the investigation findings, the improper maintenance were identified as the root cause for the device failure during the service evaluation.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.D10: concomitant med products and therapy dates: (x6) coupler ac ffl 22 device, (x3) camera head ac - c-mount device, (x1) fuslitegu_olym-acmi_3.5mmx3.0m device, 1/1/2024.

• Brand Name: COUPLER AC FFL 22
• Common Device Name: ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• 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 ; 3035526892
• MDR Report Key: 20805052
• Report Number: 1221934-2024-04240
• Device Sequence Number: 9831291
• Product Code: FEM
• UDI-Device Identifier: 10886705028627
• UDI-Public: (01)10886705028627
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 242435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown