MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE; WA22367A

Model Number	WA22367A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.Related patient identifiers: (b)(6).
Event or Problem Description
It was reported during therapeutic gynecologic surgery, myomectomy/transurethral resection (turi) under sedation, the resectoscope caused a first to second degree burn to the patient.The burn was reported to be from the genital area (pubic area) to the buttocks.The procedure was completed with the same device as planned.Burns were discovered after the procedure.The patient was treated with a cold water wash and topical ointment; the patient was initially hospitalized for original procedure and scheduled for discharge the following day, but the discharge was postponed and hospitalization was extended for three days for observation.The patient has since been discharged.There were no reports of medical intervention.Additionally, it was reported that there were no problems with the product, and the situation was monitored.As the procedure was switched urgently from normal resection to turi, the patient plate that was attached to the patient was heated quickly, leading to possible overheating.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated field:g1 - contact office email.The device was not returned to olympus for inspection, and the reported failure was not confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely that the following led to the malfunction: incomplete use of the neutral electrode or the irrigation fluid being heated above body temperature.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was provided by the customer.

• Brand Name: WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE
• Common Device Name: WA22367A
• 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: 22391670
• Report Number: 9610773-2025-04278
• Device Sequence Number: 9160723
• Product Code: KNS
• UDI-Device Identifier: 04042761066242
• UDI-Public: 04042761066242
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WA22367A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2023
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WA22026A (OUTER SHEATH); WA22040A (INNER SHEATH, FOR 26 FR. OUTER SHEATH); WA22302D (HF-RESECTION ELECTRODE, LOOP); WA22306D (HF-RESECTION ELECTRODE); WA2T412A (TELESCOPE 12°); WA2T430A (TELESCOPE 30°)
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown