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

Model Number URF-V2R

Device Problem Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

The customer returned an urf-v2r flexible video scope for evaluation.The user¿s complaint was confirmed.A visual inspection was performed on the received condition and observed the bending section skeleton broken with the bending section cover still intact.There were no signs of the broken skeleton protruding from the bending section cover.The scope passed the leak test.The bending section cover was then removed and identified the bending section skeleton tab was fully broken/detached at the insertion tube area.Additionally, there was no significant evidence of sharp areas noted with the broken/detached skeleton.In the instruction manual it states that ¿do not twist or bend the bending section with your hands.Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damage.The scope had a 28f (overhaul) repair done on (b)(6) 2019 from the previous repair history.

Event Description

The service center was informed that during an unspecified procedure, the scope appeared to be bent 3¿ from the distal end.It is unknown if the intended procedure was completed.There was no patient injury reported.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 9578303
• MDR Text Key: 220827371
• Report Number: 8010047-2020-00872
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• 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: 01/10/2020

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: URF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/10/2020
• 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