MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION GYRUS BIPOLAR RESECTOSCOPE; RESECTOSCOPE, WORKING ELEMENT

Model Number GYRUS BIPOLAR RESECTOSCOPE

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

During the transurethral resection of the bladder tumor (at the end of the resection), the ceramic end of the resectoscope inner sheath broke into pieces.All pieces were carefully removed during the cystoscopy and direct inspection of the bladder was performed by the physician.No apparent tissue damage.

• Brand Name: GYRUS BIPOLAR RESECTOSCOPE
• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 3500 corporate parkway; p. o. box 610; center valley PA 18034 061
• MDR Report Key: 3691942
• MDR Text Key: 4303852
• Report Number: 3691942
• Device Sequence Number: 1
• Product Code: FDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/19/2014

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 Model Number: GYRUS BIPOLAR RESECTOSCOPE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2014
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 66