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

Model Number	A22201C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a therapeutic turp ( transurethral resection of the prostate) procedure , after two minutes of normal use, the loop broke in half.The electrode and cord were inspected for damage prior to use.The loop did not contact any hard or metal object during use.According to the reporter, the loop disintegrated inside the patient and the fragments were washed out by the irrigation fluid, the broken piece disincarnated inside the patient.A second loop of the same kind was used to continue the procedure.The procedure time was extended by 20 minutes.The intended procedure was completed.There was no patient harm, injury or infection reported due to the event.No user injury reported.
Additional Manufacturer Narrative
The customer returned the a22201c hf-resection electrode lot# 1000081151 for evaluation due to ¿after two minutes of normal use, the loop broke in half.¿ the user¿s complaint was confirmed.A visual inspection on the received condition performed and noted the loop wire is split in half.Additionally, a microscope was used to inspect the device and found evidence of charred marks on the yellow filters from the distal end side.The broken loop ends are intact to the yellow filters and match up indicating that no pieces fell off of the loop end.A functional check was not able to be performed due to the split loop.In addition, inspection found no other damage with the device.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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.Based on the results of the investigation, the cause of the reported issue is most likely due to wear and tear.The loop at the distal end of the electrode wears out during use and may break, burn or melt.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the instructions for use, a suitable replacement device must be provided during an procedure.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE LOOP
• Common Device Name: HF-RESECTION ELECTRODE LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14116105
• Report Number: 9610773-2022-00139
• Device Sequence Number: 11845787
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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 Expiration Date: 06/29/2026
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: 1000081151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• 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