MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR

Model Number	A22201A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The technical assistance group informed the sales representative/user facility that the third party generator (megadyne) was not listed in the instructions for use manual and was not able to provide the recommended settings for use with the referenced device.The device was not returned for evaluation, therefore, the cause of the reported event could not be conclusively determined.A review of the device history records could not be performed as no lot number was provided.Additionally, multiple follow ups were made in an attempt to gather additional information on the reported event; but no additional information was obtained.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The technical assistance group was informed that the loop wire at the distal tip of the hf-resection electrode failed during procedure.The sales representative reportedly observed the procedure when the loop wire broke after thirty minutes of use.The user replaced the broken hf-resection electrode with a second-like device and was able to complete the procedure.There was no patient injury reported.The hf-resection electrode will not be returned for evaluation.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR
• Common Device Name: HF-RESECTION ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 9816407
• Report Number: 9610773-2020-00089
• Device Sequence Number: 1417892
• Product Code: GCP
• UDI-Device Identifier: 04042761021302
• UDI-Public: 04042761021302
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22201A
• Device Catalogue Number: A22201A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1