MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS RESECTOSCOPE

Catalog Number A22040A

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 04/12/2018

Event Type  Injury  

Event Description

Patient underwent transurethral resection of bladder tumor.It was noted that as the physician was advancing the sheath with resectoscope into the patient's bladder, the teflon tip came off and fell in the organ.Physician retrieved the tip using one of the bladder graspers.Patient tolerated procedure well and was discharged home same day.

• Brand Name: OLYMPUS RESECTOSCOPE
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; center valley PA 18034
• MDR Report Key: 7482404
• MDR Text Key: 107326251
• Report Number: MW5076974
• Device Sequence Number: 1
• Product Code: FJL
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A22040A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR