MAUDE Adverse Event Report: OLYMPUS OLYMPUS UROLOGY RESECTOSCOPE FOR 24 FR

Model Number A22041A

Device Problems Break (1069); Fracture (1260)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/08/2018

Event Type  malfunction  

Event Description

Pt undergoing turp noted to have significant bleeding at the end of procedure.Situation addressed by urologist resectoscope removed and 3 way foley catheter placed with the inflation of the balloon to stop bleeding.When the resectoscope was being disassembled, it was noted that the beak of the resectoscope had fractured and a piece broken off.A search for the piece was done in the room including in the trash and specimen, but was not found.Fluoroscopy was performed and intact resectoscope in the field for comparison but the fragment was not found in the pt.Decision was made not to perform cystoscopy to search for the fragment.The bleeding was controlled and a ct scan was performed later that afternoon which was confirmed by radiology to not have any evidence of a retained resectoscope beak fragment.Disclosure made to pt and family.Per urology, there have been three cases where the beak on the resectoscope either came off or fractured.

• Brand Name: OLYMPUS UROLOGY RESECTOSCOPE FOR 24 FR
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS; hamburg 22045 ; GM 22045
• MDR Report Key: 8252784
• MDR Text Key: 133375615
• Report Number: MW5083115
• Device Sequence Number: 1
• Product Code: FDC
• 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: 01/11/2019

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 Model Number: A22041A
• Device Lot Number: 184W-0015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2019
• 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 Age: 69 YR
• Patient Weight: 77