MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE; WA22067A

Model Number	WA22067A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is linked to the following patient identifier: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that after a transurethral resection of the bladder, the patient returned to the hospital with a ureter burn.No further patient information was provided.No malfunction of the device was reported.Additional information was requested but was not available at the time of this report.
Event or Problem Description
Additional information was provided by the customer.The patient is currently doing well.The customer confirmed that the generator is functioning properly and no further issues have been observed at the facility.
Additional Manufacturer Narrative
This report is being supplemented to include additional information from the customer and the results of completed investigation.Updated fields: g1, b5, h6, h11.Based on the available information and since the device was not returned for evaluation, a definitive root cause for the reported issue could not be determined.Olympus will continue to monitor the field performance of this device.

• Brand Name: WORKING ELEMENT, PASSIVE
• Common Device Name: WA22067A
• 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: 21999319
• Report Number: 9610773-2025-03281
• Device Sequence Number: 8769822
• Product Code: GCP
• UDI-Device Identifier: 04042761051620
• UDI-Public: 04042761051620
• Combination Product (Y/N): N
• Initial Reporter Country: GG
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2025

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: WA22067A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 05/10/2025
• Supplement Report FDA Received Date: 12/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ELECTROSURGICAL GENERATOR ESG-400.
• Patient Sex: Unknown