MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°

Model Number	A22201A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: (b)(6) hospital (documented here in its entirety due to character limitations in respective field).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the subject device broke outside the patient's body during a transurethral resection of the bladder tumor.The procedure and the patient's anesthesia were prolonged by 1 hour and was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the reported issue (broken electrode/1-hr procedural delay) was likely caused by usage-related wear and tear of the device.The loop wire at the distal end of the hf-resection electrode wears out during use and may break, burn, or melt.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°
• Common Device Name: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18996533
• Report Number: 9610773-2024-00897
• Device Sequence Number: 2832903
• Product Code: GCP
• UDI-Device Identifier: 04042761021302
• UDI-Public: 04042761021302
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: A22201A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown