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 returned urf-p6 scope (serial# (b)(4)) was evaluated due to ¿protruded broken skeleton¿.Investigation noted that the user¿s complaint was confirmed.A visual inspection was performed on a received condition and noted the distal end is broken.The distal end is broken at the base of the bending section area exposing metal.During inspection there is sufficient evidence of metal protruding outside the bending section cover with no sharp edge.It was determined that the elements inside the bending section are still connected together regardless of the broken skeleton.The bending section cover was removed and did not find any other sharp edges on the bending section skeleton.According to the instruction manual 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 abnormal due to the broken skeleton.The scope was purchased on february 24, 2018 and the last time the scope came in for service was july 11, 2019 for a 28f refurbishment.The leak test cannot be performed due to the broken bending section based on the evaluation, it was confirm that the user¿s complaint of a protruded broken skeleton is due to excessive force which is attributed to mishandling.

Event Description

The user facility reported a protruded broken skeleton occurred during the middle of a patient therapeutic ureteroscopy using a urf-p6 endoscope.The customer stated the damage occurred when the doctor was maneuvering the scope through the ureter while gaining access to the kidney stones.The visual on the screen showed black dots indicating that the fiber optics had been broken.The customer stated that damage occurred but no kinks or buckles were noted at the time of the reported event.The device was exchanged with a new device and the procedure was completed.The patient went home without any issues.There was no injury or trauma to the patient.The customer stated that they perform the inspection according to the ¿instruction for use¿ manual.According to the customer, the scope was sent to be reprocessed before sending the scope to the manufacturer.The certified reprocessing tech performed the inspection right after use/at reprocessing.A leak test is performed after each use of the scope.The manufacturer is used if any components require replacement or servicing.For reprocessing customer said that they do not have a reprocessing machine.They clean the scope manually followed by the use of sterrad.No other equipment was replaced during the procedure.

• 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: 9135339
• MDR Text Key: 213228296
• Report Number: 8010047-2019-03417
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• 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: 09/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2019
• 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