MAUDE Adverse Event Report: OLYMPUS HF-RESECTION ELECTRODE, LOOP, 24FR.

Model Number	A55514C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Electrode cutting loop 24 fr broke during procedure, 2 loops broke.No harm to pt reported.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24FR.
• Common Device Name: HF-RESECTION ELECTRODE, LOOP, 24FR.
• Manufacturer (Section D): OLYMPUS ; hamburg ; GM
• MDR Report Key: 7159789
• Report Number: MW5074341
• Device Sequence Number: 18855963
• Product Code: FAS
• UDI-Device Identifier: 04042761036641
• UDI-Public: 04042761036641
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/29/2017

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: 06/30/2022
• Device Model Number: A55514C
• Device Lot Number: P170006
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 101