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

Model Number URF-P6R

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was repaired and returned to the customer.Issues of this nature will continue to be tracked and trended per olympus procedures.An olympus (b)(4) capa has been opened to manage the actions related to remediation of this late mdr reporting.

Event Description

The customer returned the device to an olympus service center for evaluation.During the repair evaluation of the device, the service technician observed the upward angulation was not working due to a ruptured cable.There was no patient involvement, as this issue was identified during service.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information from the legal manufacturer regarding the final investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.As the result of dhr review by mbc, the subject device was shipped from the factory in accordance with specifications.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: a-wire was cut, the distal end came apart and was immobilized, and then the bending section was kept bent.It was difficult to specify the cause.On the basis of the following investigation results, the cause of the event was assumed that the a-wire was cut because the user erroneously performed laser irradiation within the instrument channel.In similar complaint, the event that the bending section was not moved even if the angulation control was operated was reported.The possible cause of the similar complaint was a-wire breakage.The user may have erroneously performed laser irradiation within the instrument channel.(refer to investigation result 2-4).Addendum information: in ifu (operation manual) a method about prevention of erroneous irradiation of laser is described.If the user followed ifu, the suggested event might have been prevented.The legal manufacture reported that the following description is included in ifu (operation manual) for detection method of this event.This time, the suggested event was properly detected in accordance with ifu.Inspection of the endoscope: inspection of the bending mechanism: operate the up/down angulation control lever slowly in each direction until it stops.Confirm that the bending section angulates smoothly and correctly and that maximum angulation can be achieved.In order to prevent erroneous irradiation of laser, the following description is included in ifu (operation manual).This time, the user may have deviated from ifu.However, it was difficult to specify.Do not irradiate the laser without viewing the tip of the laser probe and the aiming beam in the endoscopic image.This may cause patient injury, and the instrument channel may be damaged.

• 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: 10896330
• MDR Text Key: 226137342
• Report Number: 8010047-2020-09395
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2021

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-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1