MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE; FIBEROPTIC LIGHT CABLE

Model Number	WA03310A
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Based on the results of the investigation, it is likely that the following led to the malfunction: light projectors emit a large amount of energy, which causes the connections of the light guide cable as well as the connection and the distal end of the optics to heat up considerably.This can lead, for example, to the melting of heat-sensitive objects or even to skin burns if the endoscopic equipment is placed on a heat-sensitive object or a patient immediately after use or, worse still, while light is still being emitted.However, a definitive root cause of the reported event could not be identified.This issue is addressed in the instructions for use (ifu): in the ifu information is provided to use the products correctly and with caution, e.G.: caution advice not to place endoscopic equipment on patient skin or flammable/heat-sensitive materials an inspection of the products before each use is described in the ifu, such a defect therefore should be discovered before use.A replacement of defect devices and contact to olympus representatives is suggested.Caution advice that light emission part/distal end & connectors get hot.Caution advice to set output power of supply unit as to the minimum level that is needed for a sufficient illumination.Caution advice to switch supply unit off if not used¿ olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that when the light guide cable was placed on top of a drape during treatment, the drape melted.The issue occurred during an unknown procedure.There were no reports of patient or user harm.

• Brand Name: LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE
• Common Device Name: FIBEROPTIC LIGHT CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19336282
• Report Number: 9610773-2024-01260
• Device Sequence Number: 2607605
• Product Code: HBI
• UDI-Device Identifier: 04042761082303
• UDI-Public: 04042761082303
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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 Model Number: WA03310A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WA4KL530 : TELESCOPE "ULTRA", 5.4 MM, 30°.
• Patient Sex: Unknown