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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that after twenty minutes into a transurethral resection of bladder (turb) while using hf-resection electrode, button, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs., along with the working element, there was no resection.The doctor instructed the nurses to check the saline solution and it was ok so they attempted again with success.There was a unexpected loud sound followed by smoke.It was stated that the physician was scared and swiftly pulled the instrument from the patient resulting in a bladder perforation.The procedure was transitioned to an open procedure to close the perforation.The patient was stated to be stable after the open surgery.This mdr requires 2 reports.The related patient identifiers are as follows: (b)(6): hf-resection electrode, button, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs., for turis, model wa22557c.(b)(6): working element, passive, for resection in saline, model wa22367a.This medwatch report is for patient identifier (b)(6), model wa22367a.
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 or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (updates to field d9, g2, and h3).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.The complete evaluation results are as followed: missing electrode seal at the main body of the working element and non-olympus high frequency cable.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 suggested event occurred due to a defective, non-olympus high frequency cable.However, the specific root cause of the suggested 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: 18450953
• Report Number: 9610773-2024-00090
• Device Sequence Number: 7092286
• Product Code: KNS
• UDI-Device Identifier: 04042761066242
• UDI-Public: 04042761066242
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: 20908-0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• 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: CONNECTION CABLE - BOWA.; ELECTROSURGICAL UNIT - STORZ; HF-RESECTION ELECTRODE, MODEL WA22557C.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown