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

Model Number A55514C

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2017

Event Type  malfunction  

Event Description

Electrode cutting loop 24 fr broke during procedure, 2 loops broke.No harm to pt reported.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24FR.
• Type of Device: HF-RESECTION ELECTRODE, LOOP, 24FR.
• Manufacturer (Section D): OLYMPUS ; hamburg ; GM
• MDR Report Key: 7159789
• MDR Text Key: 96362873
• Report Number: MW5074341
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04042761036641
• UDI-Public: 04042761036641
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: A55514C
• Device Lot Number: P170006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 101