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

Model Number	WA22305S
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience, and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation, or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during a therapeutic transurethral resection of a bladder tumor (turbt) procedure, the loop wire at the distal end of the hf resection electrode broke and fragments may have fallen into the patient¿s bladder.This happened when the esg-400 generator was unplugged, and restarted after it had performed an automatic restart.The intended procedure was completed using a similar device, and there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical system corporation in hinode, japan (omsc), (returned to omsc on 2020-10-09).The evaluation at omsc hinode confirmed that the loop wire at the distal end of the electrode is broken and that the ends of the wire have melted into balls.The damage found was attributed to use-related wear and tear.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection electrode without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", SMALL LOOP, 24 FR., 12-30, IN SALINE
• Common Device Name: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10618760
• Report Number: 9610773-2020-00232
• Device Sequence Number: 19512854
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 06/30/2024
• Device Model Number: WA22305S
• Device Catalogue Number: WA22305S
• Device Lot Number: 1000046462
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 04/23/2021
• 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: OLYMPUS HF UNIT "ESG-400"; OLYMPUS HF UNIT "ESG-400"