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

Model Number URF-V2

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.A visually inspection was performed on the returned device and found leaking in channel at the distal end.An additional leak was found on the bending section with metal sticking out.The image quality was checked and noted to be normal.The instruction manual states ¿do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leakage.Do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connector, and light guide connector.The endoscope may be damaged, and water leakage and/or breakage of internal parts like the image sensor cable can result.¿.

Event Description

The service center was informed that fluid invasion was noted on the scope during reprocessing.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and device manufacturer date.Please see the updates.The legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.According to the investigation result, the metallic components are protruded from torn bending rubber the cause of this event was determined as breakage of the bending tube.The lm reported that the most probable causes for the reported event are as follows: when the endoscope is inserted into the lower kidney calyx or urinary tract, the endoscope is excessively pushed while its bending section is bent.Ifu stated the detection method of this event as follows: this time, the reported event was properly detected in accordance with ifu.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.In order to prevent occurring this event, warnings and cautions about handling the endoscope which may result in damages in the bending tube is described in the addendum ifu ¿instructions for safe use¿ in the package contents.If the user follows the instruction, damages in the bending tube can be eliminated.However, because of deviation of the user¿s usage from the instruction, it was assumed that the bending tube was damaged.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10423564
• MDR Text Key: 223647120
• Report Number: 8010047-2020-05588
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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: 07/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2020
• 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