MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OBTURATOR, 24 FR.; HF-RESECTION ELECTRODE

Model Number	A22081A
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	05/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to (b)(6).
Event or Problem Description
It was reported that during an unknown procedure, there was a bladder perforation.The physician felt as if it was due to an electrical problem with the resectoscope.The patient had to undergo a laparotomy due to the perforation.Additional information was requested multiple times, but not received.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus, and no abnormalities were observed.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, no device abnormalities were noted.Therefore, the root cause of the event could not be determined.This supplemental report includes additional information received from the customer.B5 updated accordingly.A correction has been made to d1, d2, d4, g2, and g4 from the initial medwatch.An update has been made to d9 and h3.Also, information has been added to b2, h4, and h6.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the incident occurred during a bladder resection using bipolar energy.The bladder perforation occurred when the surgeon approached the patient¿s obturator nerve.The patient was not injured by electric current and/or shock.The generator did not display an error message.The generator was programmed to a ¿classic¿ bipolar setting recommended by olympus.Due to the bladder perforation, an emergency laparotomy was performed.This resulted in a 1-hour procedural delay.The surgeon reported the incident to the hospital¿s biomedical team.

• Brand Name: OBTURATOR, 24 FR.
• Common Device Name: HF-RESECTION ELECTRODE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19538767
• Report Number: 9610773-2024-01475
• Device Sequence Number: 20416403
• Product Code: GCP
• UDI-Device Identifier: 04042761021159
• UDI-Public: 04042761021159
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K931994
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22081A
• Device Lot Number: 21502
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 CABLE.; OUTER SHEATH.; WORKING ELEMENT.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown