MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL LIGHT GUIDE OLYM-ACMI_5.0MMX4.0M; FIBREOPTIC LIGHT CABLE

Model Number	242388
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	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by sales rep that during a laparoscopic cholecystectomy procedure on (b)(6) 2022, it was observed that the light guide olym-acmi_5.0mmx4.0m device was not producing enough light to see.During in-house engineering evaluation, it was determined that the epoxy potted end was crashed and broken.Another like device was used to complete the procedure with one minute of delay.There were no adverse patient consequences 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 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.Additional narrative: udi: (b)(4).Reporter is a j&j sales representative.The expiration date and device manufacture date are currently unavailable.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Upon visual inspection revealed marks of wear on the device.It could be observed the epoxy potted end crashed and broken.Also, it could be detected stains by use in the female endtip side.Finally, no visible damages on the cable.Due to the condition of the epoxy potted end, the functional test cannot be performed.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.According with the visual inspection results, this complaint can be confirmed.The broken condition of the epoxy potted end can be attributed to procedural variables, such handling of the device or product interaction during procedure.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures, the constant manipulation between surgeries and sterilization process can lead to a broken epoxy potted end.However, it cannot be conclusively affirmed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Device history lot 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.

• Brand Name: LIGHT GUIDE OLYM-ACMI_5.0MMX4.0M
• Common Device Name: FIBREOPTIC LIGHT CABLE
• 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: 15114426
• Report Number: 1221934-2022-02254
• Device Sequence Number: 5464728
• Product Code: FCW
• UDI-Device Identifier: 10886705028832
• UDI-Public: 10886705028832
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: 242388
• Device Catalogue Number: 242388
• Device Lot Number: WO143319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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