MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to service center for an evaluation and the user's complaint was confirmed.A visual inspection was performed on the returned device and noted a piece of the bending section cover is torn off at the middle section of the distal end.There is evidence of cuts just below the torn cover.The scope was further inspected and noted blue discoloration on the bending section cover glue with multiple third party components.This scope is part of a post counter measure design.According to the ifu it states ¿do not twist or bend the bending section with your hands, equipment damage may result¿.The bending section was manipulated; the movement is consistent and normal.The scope was purchased on (b)(6) 2018 and the last time the scope came in for service was (b)(6) 2019 for a 28f refurbishment.The leak test cannot be performed due to the torn bending section cover.Based on the evaluation service center was able to confirm the user¿s complaint as the cause to the torn off bending section cover is due to mishandling.The blue discoloration on the glue is due to third party repairs.

Event Description

The service center was informed that at the end of the procedure, it was noticed there was tear in the rubber.The user reported the scope had gotten snagged on a stone that was imbedded in the patient¿s ureter upon exiting.When reprocessing, a piece of the rubber came off of the scope.The user further reported that there was metal protruding but no broken sections of the bending portion of the scope were noted.The leak test is performed after each use of the scope.There was no patient injury reported and procedure was completed.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8851719
• MDR Text Key: 152973963
• Report Number: 8010047-2019-02787
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1