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

Model Number URF-P6R

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.A visual inspection on the received condition was performed and noted the distal end is broken.The distal end is broken from the base of the bending section area exposing metal.During inspection there is sufficient evidence of metal protruding outside the bending section cover.Based on the evaluation and the cause of the broken bending section skeleton is most likely due to the application of excessive force, which is related to user mishandling of the device.The scope was purchased on (b)(6) 2013 and the last time the scope came in for service was (b)(6) 2019 according to the instruction manual it states ¿do not twist or bend the bending section with your hands, equipment damage may result¿.

Event Description

The returned scope has a broken skeleton that is protruding and there is a cut in the a-rubber.There was no patient injury or adverse outcome reported as a result of the issue.

• 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: 8967520
• MDR Text Key: 213701869
• Report Number: 8010047-2019-03203
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• 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