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

Model Number URF-P6

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The customer¿s complaint was confirmed as excessive fibers broken on image.Further inspection found leaking on bending section cover with the metal broken and sticking out.The legal manufacture will further investigate this matter.The instruction manual provides several warnings to prevent scope damage.Do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leakage inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.

Event Description

The service center was informed that the scope¿s fibers were noted to be broken and image was unstable.There was no further damage or abnormalities observed other than the broken fibers.The scope was stored in a container.It is unknown how the scope damage occurred or how the scope was reprocessed.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.However, the legal manufacturer reported that the most probably cause for the reported event is the following: -when access the scope to the lower kidney calix and/or the ureter, access the scope excessively while distal end is bent.The detecting method for the suggested event is described in ifu as follows.It is determined that the suggested event was properly detected in accordance with ifu section ¿3.3 inspection of the endoscope.¿ ¿inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ ¿instructions for safe use¿ instructs how to manipulate the scope safely.Decreasing bending tube breakage is possible by manipulating the scope in accordance with ifu.However, bending tube breakage may have occurred in this case for there may have been deviation from ifu.

• 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
• MDR Report Key: 10481952
• MDR Text Key: 224635774
• Report Number: 8010047-2020-06103
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• 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: 07/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1