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

Model Number	A22202C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced device was not returned to olympus for evaluation.Therefore, the cause of the reported event is unknown.However, the investigation is ongoing.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
Olympus received a medwatch ((b)(4)) from the fda via mail.The medwatch states that "during the procedure the surgeon stated the resectoscope loop broke off in the patient." the date of event was in(b)(6) 2020.No patient injury was reported.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the customer as part of the investigation, olympus followed up with the user facility to obtain additional information.The risk manager at the user facility reported that the event occurred on (b)(6) 2020.No additional information was provided.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.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 reported issue can most likely be attributed to wear and tear.The loop at the distal end wears out during use and may burn or melt if broken.Olympus will continue to monitor complaints 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
• MDR Report Key: 10719049
• Report Number: 9610773-2020-00241
• Device Sequence Number: 19661205
• Product Code: GCP
• UDI-Device Identifier: 14042761036662
• UDI-Public: 14042761036662
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K954488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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 Expiration Date: 12/31/2022
• Device Model Number: A22202C
• Device Catalogue Number: A22202C
• Device Lot Number: 1000037291
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR