MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS TURIS; ELECTRODE

Catalog Number WA22503D

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/30/2014

Event Type  malfunction  

Event Description

During resection for transurethral resection of the prostate (turp) procedure, the bipolar loop snapped.It is unknown if portion of loop has broken off.Loop was replaced and same thing happened with second loop.A third loop was given and case completed.

• Brand Name: TURIS
• Type of Device: ELECTRODE
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate pkwy; center valley PA 18034
• MDR Report Key: 4608403
• MDR Text Key: 5695875
• Report Number: 4608403
• Device Sequence Number: 1
• Product Code: FAS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/06/2015

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: Invalid Data
• Device Catalogue Number: WA22503D
• Device Lot Number: 1416P02L001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 112