MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ENDOSCOPE AND ACCESSORIES

Model Number	A22201C
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is pending return for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported to olympus that when using a hf-resection electrode, the loop had vaporized during the therapeutic procedure (cystoscopy with transurethtral resection of bladder tumor).Cautery settings were 180 cut and 55 fulgrate.There was no patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on additional information, device received, and correction to b3.The device was returned and the user¿s complaint was confirmed.A visual inspection of the device observed the cutting loop wire had broken off/split in half.There was an indication of charred marks on the remaining loop wire that was still intact to the device.Additionally, there was evidence of charred marks also noted with both yellow filters from the distal end area.In addition, the outer blue sheath is bent.There were no other damages found with the device.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The condition of the patient was not impacted by the failure.The procedure was able to be completed with another device of the same model.The information regarding the device that was used to complete the procedure is unknown.The procedure was not prolonged.The patient's anesthesia or sedation was not extended.The procedure did not need to be cancelled or postponed.The procedure did not need to be cancelled or postponed.There was no medical intervention required.It is not available as to whether any other subject devices connected when the failure occurred.The patient demographics are not available.
Additional Manufacturer Narrative
Updated: h6, h11.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, a definitive root cause of the reported loop breakage/vaporization issue could not be determined, however, the issue was likely due to wear as a result of repetitive use.It was additionally found that the electrode was deformed/bent, likely due to excessive force.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, the ifu states that a suitable replacement device must be provided during an application.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Common Device Name: ENDOSCOPE AND ACCESSORIES
• 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: 17542268
• Report Number: 9610773-2023-02228
• Device Sequence Number: 7570401
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790071
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22201C
• Device Lot Number: 1000106892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 07/12/2024
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/19/2023; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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
• Patient Sex: Unknown