MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, BUTTON; ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES

Model Number	WA22557C
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 wa22557c.
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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, the cause of the reported event is likely not due to the electrode, but to a defective, non-olympus hf-cable.However, the subject device was not returned to olympus for evaluation.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, BUTTON
• Common Device Name: ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
• 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: 18452268
• Report Number: 9610773-2024-00089
• Device Sequence Number: 7155137
• Product Code: FAS
• UDI-Device Identifier: 14042761068342
• UDI-Public: 14042761068342
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K120418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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: WA22557C
• Device Lot Number: 1000067064
• Was Device Available for Evaluation?: No
• 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: 02/21/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNECTION CABLE - BOWA; ELECTROSURGICAL UNIT - STORZ; WORKING ELEMENT, MODEL WA22367A
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown