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

Model Number	A22201D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that during two different therapeutic transurethral resection of bladder tumor, this resection electrode loops broke.The first case, the loop broke completely off.The second case, the loop broke in half.Both procedures were prolonged due to the need to obtain replacement loops and verify the broken pieces were not left in the patient.The first case was 1 3/4 hours and the second case 2 hours.In both occurrences, the loop was removed successfully and the procedures were completed successfully using a similar device.X-rays were obtained to confirm broken pieces were not left in the patient.There were no reports of patient or user harm associated with this event.Patient identifiers: (b)(6) - 1st case of 2 broken resection electrode loop.(b)(6) - 2nd case of 2 broken resection electrode loop.This report is for (b)(6).
Additional Manufacturer Narrative
Complete brand name: hf-resection electrode, loop, 24 fr., 0.2 wire, 12°, sterile, single use, 12 pcs.This device was returned for evaluation.The device was returned in the original packaging however opened and used.Broken loop was confirmed.The distal end where the damaged loop was examined under a microscope, char marks and slightly melted yellow insulation on the forks were identified.The shaft and the proximal end have no signs of excessive bends or discrepancies.It was observed that the forks on the distal end are bent and the forks are neighboring.No functional tests were performed as the loop was broken and damaged.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report has been submitted on an importer medwatch, report # 2429304- 2023- 00047.
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 less than 1 year since the subject device was manufactured.Based on the results of the investigation, the reported issue (broken electrode loop/wire) was likely due to wear and tear of the device.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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: HF-RESECTION ELECTRODE, LOOP
• 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: 16653072
• Report Number: 9610773-2023-00923
• Device Sequence Number: 12243295
• Product Code: GCP
• UDI-Device Identifier: 14042761036655
• UDI-Public: 14042761036655
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: A22201D
• Device Catalogue Number: A22201D
• Device Lot Number: 1000103882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CYSTOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown