MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE LOOP; RESECTOSCOPE LOOPS

Model Number	A22201C
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D1.Full device name: hf-resection electrode, loop, 24 fr., 0.35 wire, 12°, sterile, single use, 12 pcs.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A user facility reported to olympus that during cystoscopy with transurethral resection of a bladder tumor, while using the "hf-resection electrode, loop, 24 fr., 0.35 wire, 12°, sterile, single use" to dissect tissue, the loop of the electrode "vaporized" in the bladder.The device was removed from the patient's bladder and replaced with a new loop.It was unknown how the device was retrieved.No delay's or injuries occurred, and the procedure was completed successfully.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of the device history record revealed that the device was shipped in accordance with the specifications and had no nonconformity at manufacturing.Based on the results of the investigation, it was noted that the cause of the reported issue was most likely due to wear and tear as well as improper handling.The loop showed wear from use, evident in the tapered, melted, chafing wire in the area of the break.Additionally, the insulating tubes had been subjected to high thermal stress and were partially melted.One ceramic sleeve had been exposed and broken, indicating the presence of a mechanical force.It should be noted that a fragment was missing and its whereabouts were unknown.A short circuit between the optics and the electrode could be ruled out, as no error message from the generator had been reported.Therefore, the device did not satisfy its specifications, confirming the occurrence of the event.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE LOOP
• Common Device Name: RESECTOSCOPE LOOPS
• 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: 17213673
• Report Number: 9610773-2023-01747
• Device Sequence Number: 3022107
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K903323
• 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,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: 1000090908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown