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

Model Number URF-V2

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center and is pending evaluation.The cause of the reported event cannot be determined at this time.

Event Description

The service center was informed that during reprocessing the scope¿s bending section rubber was noted to be torn with metal sticking out.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation and lm investigation.The urf-v2r (uretero-reno videoscope) with serial # (b)(6) was returned to the service center for an evaluation.The scope was received and inspected by the estimation technician.A cut on the bending section cover with the bending skeleton exposed was noted; no sharps point was observed during the inspection.The bending section also displayed a deformity at the proximal end.Market quality received the scope from estimation.A visual inspection was performed and observed the same failure.In addition, the bending section cover was removed to further evaluate the conditions and observed a breakage on the bending skeleton approximately 4mm from the bending section adhesive.The breakage of the bending skeleton displayed no sharps surface or point.Additionally, a microscope was used to inspect and noted characteristic of excessive stress applied at the proximal end of the bending section skeleton which cause it to break.No other deformities observed during the evaluation.According to the instruction manual on page 13 under the caution section stating that ¿do not attempt to bend or twist the endoscope¿s insertion section with excessive force.The insertion section may be damaged.Do not twist or bend the bending section with your hands.Equipment damage may result¿.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reported that the most probable cause for the reported event is as follows: the cause was breakage of the bending tube.The cause of breakage of the bending tube cannot be specified.On the basis of the following information, it was assumed that a way of operation by the user resulted in application of excessive force to the bending section.The following description is included in ifu for detection method of this event.Although the user reported the suggested event, mbc was not able to confirm it.Therefore, the user might have deviated from ifu.Precautions : perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.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.In order to prevent occurring the suggested event, the following description is included in ifu.Because the suggested event occurred, the user might have deviated from ifu.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 may be 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.Do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.This scope has been identified as a post counter measure device.¿if the endoscope is excessively pushed while its bending section is bent when the user inserts the subject device into the lower kidney calyx or urinary tract¿, the bending tube might be broken.The legal manufacturer reported that in order to prevent occurrence of adverse event, manufacturer changed design of the bending tube not to damage the patient¿s body cavity even if the bending tube was broken.The legal manufacturer confirmed via dhr that the subject device was shipped from the factory in accordance with specifications.

• 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
• MDR Report Key: 10556866
• MDR Text Key: 222089267
• Report Number: 8010047-2020-06687
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1