MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE; FIBREOPTIC LIGHT CABLE

Model Number	WA03300A
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device evaluation, while using the light cable, the tip of the camera head was found to be scorched.There were no reports of patient involvement.
Additional Manufacturer Narrative
Updated: h4, h6, h11 this report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause of the reported heat generation could not be determined, however, the issue was likely due to the fiber glass sleeve serving as a strain relief became torn due to a high tensile load and bending stress.Due to tearing of the tension relief, the protective hose, the inner hose and/or the metal coil can slip out of the sleeve.If the metal coil slips out, the exposed edge of the sleeve can cause the glass fibers to break, leading to deterioration of the light transmission and heat conduction.The issue is the result of user handling/mishandling due to excessive bending and tensile stress on the light guide cable.Olympus will continue to monitor field performance for this device.

• Brand Name: LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE
• Common Device Name: FIBREOPTIC LIGHT CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18932524
• Report Number: 9610773-2024-00767
• Device Sequence Number: 14600335
• Product Code: HBI
• UDI-Device Identifier: 04042761082297
• UDI-Public: 04042761082297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: Other
• Device Model Number: WA03300A
• Device Lot Number: 204W0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown