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

Model Number URF-P6R

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and found to be damaged with metal protruding from the bending section cover.The cause cannot be conclusively determined.However, review of similar complaint showed that this type of damage can be attributed to user handling.Per the ifu: never use the endoscope on a patient if an irregularity is observed.Damage or an irregularity in the endoscope may compromise patient or user safety and may result in more severe equipment damage.

Event Description

It was reported that during estimation, the bending section of the device was found to be damaged with metal protruding from the bending section cover.This event happened during reprocessing and there was no patient involvement.

Manufacturer Narrative

This supplemental report was submitted to provide new information from the oem's (omsc) investigation.The oem conducted the investigation of the bending rubber was broken/torn/ruptured with metal protruding based on the service/repair event.Additionally, a review of the device history record (dhr) confirmed the subject scope was shipped in accordance with specifications via dhr.A review of the event details could not confirm a report of the abnormality during procedure.The noted bending rubber was broken/torn/ruptured with metal protruding is a known issue and has previously been investigated.A design change was completed in order to improve safety to the patient.Based on previous investigations of the kinked/cracked bending tube, the cause of the event can potentially occur when accessing the scope to the lower kidney calix and/or the ureter and access of the scope excessively while distal end is bent; excessive stress on bending tube during procedure.The instructions for safe use instructs how to manipulate the scope safely and how to conduct inspection in detail.Abnormality is detectable safely by manipulating the scope and conducting inspection in accordance with ifu.The oem determined abnormality was safely detected in accordance with ifu for there was no adverse event in this case.The product¿s ifu describes on bending tube breakage as follows.Since bending tube breakage occurred, there may have been deviation from the followings as stated in the ifu.4.1 precautions:caution: do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section maybe damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist.3-7.Labeling review (include ifu) :attached ifu:¿instructions for safe use¿ instructs how to manipulate the scope safely and how to conduct inspection in detail.Abnormality is detectable safely by manipulating the scope and conducting inspection in accordance with ifu.We determined abnormality was safely detected in accordance with ifu for there was no adverse event in this case.

• 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: 9970649
• MDR Text Key: 205363025
• Report Number: 8010047-2020-02244
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• 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: 03/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2020
• 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