MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", SMALL LOOP, 24 FR., 12°-30°, IN SALINE; ELECTRODES

Model Number	WA22305S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that, ¿during the transurethral resection of the prostate procedure, the tip of the loop electrode broke and fell out into the body.¿ the tip that fell off has already been recovered from the patient, and another electrode was used to complete the intended procedure, with no impact on the patient or health hazard.It was reported the surgeon may have used the electrode while twisting it slightly.
Additional Manufacturer Narrative
Photos of the device were provided of the referenced device and the customer¿s reported problem was confirmed.The entire loop wire at the distal tip of the device was confirmed to be broken off.The review of the device history records for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.The investigation is still in progress; therefore, the cause of the broken loop wire cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).Upon inspection of the device, it was noted that the wire fragment ends were warped, which suggests an external force was applied.Furthermore, the contour of the loop was no longer in place and there were blank spots at the wire ends.The yellow insulating tube had also been mechanically damaged.This damage indicates mechanical contact with another surgical instrument or similar.There was no evidence of thermal damage.Based on the results of the investigation, the root cause could not be conclusively determined.It is likely the reported event occurred due to the use of excessive force from improper handling.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", SMALL LOOP, 24 FR., 12°-30°, IN SALINE
• Common Device Name: ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16850689
• Report Number: 9610773-2023-01189
• Device Sequence Number: 18024790
• Product Code: FAS
• UDI-Device Identifier: 14042761082393
• UDI-Public: 14042761082393
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152092
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: WA22305S
• Device Catalogue Number: WA22305S
• Device Lot Number: 1000096771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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