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

Model Number URF-V2

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Due diligence has been executed for this event.Event date is not know.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Upon inspection and testing, it was observed that the bending section of the device was broken with metal sticking through the distal end insulation rubber (a-rubber).This was attributed to user handling.The device failed the leak test.The device was leaking from the holes in the a-rubber.The user¿s complaint was confirmed.Other incidental observations were no movement of the control knob and angulation, and buckle on the light guide tube.

Event Description

As reported for this event, during reprocessing the device failed the leak test.The leak was found about three and a half inches from the distal tip.There is no reported harm or adverse impact to any patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device was shipped in accordance with specifications.The device was repaired in march of 2020.Upon inspection and testing, it was observed that the bending section of the device was broken with metal sticking through the distal end insulation rubber (a-rubber).As a countermeasure from a previous capa, the design of the bending tube was changed so as not to damage the patient¿s body cavity even if the bending tube was broken.The countermeasure has been effective.In order to prevent occurring this event, warnings and cautions about a way of 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 decreased.However, because of deviation of the user¿s usage from the instruction, it is likely that the bending tube was damaged.The instructions for use (ifu) includes the following statements: ¿ 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.

• 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: 10719474
• MDR Text Key: 225942056
• Report Number: 8010047-2020-08011
• Device Sequence Number: 1
• Product Code: FGB
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1