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

Model Number	WA03310A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, (combination use ) of the device wair130a (telescope rir) and wa03310a (light guide cable) were used in a therapeutic laparoscopic ileocecal resection.The gown worn by the doctor during the wound closure process was burnt.It was reported that in the second half of the procedure, while the intraperitoneal operation was over and the doctor was closing the wound, wair130a and wa03310a were put in the pocket of the drape without turning off the light source., while the doctor was closing the wound, the gown the doctor was wearing was scorched.The heat from the tip of the optical viewing tube scorched the gown.There was no injury or harm due to scorching.There was no patient harm or user injury reported as the result of the event.The intended procedure was completed without any problems.Per the report in addition, there was no particular issue with the lightguide/lightsource ( cll-s700).This event includes two (2) reports capturing the 2 devices addressed on this event.Report with patient identifier (b)(6)- telescope ir model wair130a sn: (b)(4).Report with patient identifier (b)(6)- light-guide cable model wa03310a lot 229w0002.This report being submitted is for report with patient identifier (b)(6)- light-guide cable model wa03310a lot 229w0002.
Additional Manufacturer Narrative
The subject device was not returned for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
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.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the reported issue is likely due to user mishandling.While the light source is turned on and covered, it can lead to heating of the area to a greater extent depending on the intensity of the illumination.In this case, the distal end of the telescope was not intended to be covered (for a long duration) which caused the burn to the surgeon¿s gown.Olympus will continue to monitor field performance for this device.

• Brand Name: LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE
• Common Device Name: LIGHT-GUIDE 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16704436
• Report Number: 9610773-2023-01001
• Device Sequence Number: 3676872
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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 Catalogue Number: WA03310A
• Device Lot Number: 229W0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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: CLL-S700-.LIGHTSOURCE.WAIR130A .TELESCOPE IR
• Patient Sex: Unknown