MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12-30, ESG TURIS

Model Number	WA22707S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The original equipment manufacturer (oem) conducted a review of the device history records for the concerned device and no anomalies were noted.The subject device was not returned for evaluation; therefore, the root cause of the reported malfunction cannot be determined at this time.However, the investigation is ongoing; if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
During the middle of a transurethral resection of a bladder tumor procedure, the loop of the high frequency electrode came off and fell inside the patient.The broken loop fragment was retrieved from the patient as the physician was able to flush the tip successfully.The nurse at the user facility further reported the physician was able to completed the intended procedure using a similar device without delay.No other devices were replaced during the case.Both the endoscope and the plasma loop were inspected prior to use.No patient injury was reported.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the legal manufacturer.The legal manufacturer performed the device history records for this device; no abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The legal manufacturer determined, that usage-related wear and tear has contributed to the breakage.It is a known damage pattern depicting the loop wire at the distal end of the electrode wearing out during use which may result in a breakage.Olympus will continue to monitor complaints for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12-30, ESG TURIS
• Common Device Name: HF-RESECTION ELECTRODE "PLASMALOOP"
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11035977
• Report Number: 9610773-2020-00295
• Device Sequence Number: 19148581
• Product Code: FAS
• UDI-Device Identifier: 14042761085363
• UDI-Public: 14042761085363
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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 Model Number: WA22707S
• Device Catalogue Number: WA22707S
• Device Lot Number: 1000055619
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2020
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1