MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS; PLASMA LOOP ELECTRODE SINGLE USE

Model Number	WA47706S
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).

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS
• Common Device Name: PLASMA LOOP ELECTRODE SINGLE USE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 16653125
• Report Number: 2429304-2023-00048
• Device Sequence Number: 14945558
• Product Code: FAS
• UDI-Device Identifier: 14042761085530
• UDI-Public: 14042761085530
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2023
• Report Date (Section F): 03/01/2023

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: WA47706S
• Device Catalogue Number: WA47706S
• Device Lot Number: 1100409762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CYSTOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown