MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL FUSLITEGU_OLYM-ACMI_3.5MMX3.0M; LIGHT, SURGICAL, FIBEROPTIC

Catalog Number	242386
Medical Device Problem Codes	Break (1069); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified arthroscopy procedure, the fuslitegu_olym-acmi_3.5mmx3.0m device light transmitting bundle could not conduct light normally and the interface was damaged.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.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.H10 additional narrative: investigation summary: e1: the reporters complete facility address was not provided.The product was not returned to depuy synthes, however a photo was provided for evaluation.Visual inspection of the returned photo found the device surface with signs of usage.In addition, the female instrument end tip was detached form the adaptor.The image did not provide evidence regarding the light transmittance issue, therefore this condition cannot be confirmed.No other anomalies were noted.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the fuslitegu_olym-acmi_3.5mmx3.0m would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life.The manufactured date of this device is august 2023 and hence indicates this device is almost 3 years old.Properly handling and attention to the approved use of the device diminishes the risk of failure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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.Device history lot: a manufacturing record evaluation was performed for the finished device and no non-conformance was identified.

• Brand Name: FUSLITEGU_OLYM-ACMI_3.5MMX3.0M
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• 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: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24268624
• Report Number: 1221934-2026-00551
• Device Sequence Number: 10726050
• Product Code: FST
• UDI-Device Identifier: 10886705028818
• UDI-Public: (01)10886705028818(10)WO197214
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K901035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: 242386
• Device Lot Number: WO197214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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