MAUDE Adverse Event Report: OLYMPUS AMERICA INC OLYMPUS CYSTOSCOPE URF - P6R

Model Number URF-P6R

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 11/14/2018

Event Type  Injury  

Event Description

Physician was performing a cystoscopy, left ureteroscopy, laser lithotripsy for 4 hours more.When the scope was removed, there was stone and part of the ureter on the cystoscope.Pt had to have an add'l stent placed, left nephrostomy tube placed and a foley catheter placed.Some of the staff reported seeing sparks related to the laser on the screen.I am still interviewing staff and looking for info on the disposable fiber optic.The investigation does not indicate whether or not this event is operator error or equipment malfunction.

• Brand Name: OLYMPUS CYSTOSCOPE URF - P6R
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA INC; 3500 corporate pkwy; center valley PA 18034
• MDR Report Key: 8142523
• MDR Text Key: 129760964
• Report Number: 8142523
• Device Sequence Number: 1
• Product Code: FAJ
• 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: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/16/2018
• Device Age: 18 MO
• Event Location: Hospital
• 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): Other; Disability
• Patient Age: 65 YR
• Patient Weight: 60