MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS RESECTION ELECTRODE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number 24F

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2016

Event Type  malfunction  

Event Description

Surgeon was using cutting loop in the bladder to resect a tumor when the loop broke off into the bladder.Surgeon continued procedure with a new loop in hopes of retrieving the broken loop at the end of procedure.After procedure complete, the device was not seen in bladder on cystoscope.An x-ray was performed to see if loop was still in bladder.Loop was not visualized.

• Brand Name: RESECTION ELECTRODE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate parkway; center valley PA 18034
• MDR Report Key: 5789656
• MDR Text Key: 49426157
• Report Number: 5789656
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2016

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: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: 24F
• Device Catalogue Number: A22205C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 67