MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE; XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT

Model Number	WA22367A
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
During a therapeutic transurethral resection of the prostate, bladder puncture, and transurethral holmium laser lithotripsy for bladder stones using working element, passive, for resection in saline and hf unit "esg-400" the electrocautery did not perform and reported to short circuited.Resulting in an increase of intraoperative bleeding and a decrease in treatment effectiveness for the patient.The hf unit "esg-400" had an error code of e006.Due to the reported malfunction they were not able to effectively alleviate urinary interruption, painful urination, and hematuria.The anesthesia time for the surgery was extended, and a similar device was used to continue the procedure.This complaint requires 2 reports.The related patient identifiers are as follows: (b)(6) - working element, passive, for resection in saline.(b)(6) - hf unit "esg-400" this medwatch represents (b)(6) - working element, passive, for resection in saline.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the author (see b5).
Event or Problem Description
The customer later confirmed the increase in intraoperative bleeding was minor and no medical interventions were required.The anesthesia time was extended by 5 minutes.The procedure was completed and the malfunction did not affect the outcome of the procedure.
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.Based on the results of the investigation, it is likely the reported event occurred due to the electrical interface has lost function.However, the root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE
• Common Device Name: XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
• 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: 18334956
• Report Number: 9610773-2023-03638
• Device Sequence Number: 6711976
• Product Code: KNS
• UDI-Device Identifier: 04042761066242
• UDI-Public: 04042761066242
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030194
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2024

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
• Device Lot Number: 19705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 07/18/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 12/20/2023; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2019
• 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: HF UNIT "ESG-400".
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown