MAUDE Adverse Event Report: GYRUS ACMI, INC. GURUS A; CUTTING LOOP ELECTRODE

Catalog Number MLE-26-010

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Doctor performing a transurethral resection of bladder tumor using gyrus acmi 26fr loop with force triad cautery settings of cut 210 coag 80.During procedure, tip of loop burned through.Another loop opened and settings decreased.The next two loops burned through as well.All with the same lot #.Settings again decreased after each loop failure.The fourth loop functioned properly for the rest of the procedure.

• Brand Name: GURUS A
• Type of Device: CUTTING LOOP ELECTRODE
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike rd; southborough AA 01772 210
• MDR Report Key: 4080798
• MDR Text Key: 4743209
• Report Number: MW5038113
• Device Sequence Number: 1
• Product Code: HIH
• 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: 09/05/2014
• 3 Devices were Involved in the Event: 1 2 3

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: 06/01/2018
• Device Catalogue Number: MLE-26-010
• Device Lot Number: 762055FF
• Other Device ID Number: MLE-26-010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR