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

Model Number URF-V2R

Device Problems Crack (1135); Fluid/Blood Leak (1250); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been received by olympus for physical evaluation.The investigation is ongoing.Physical evaluation of the returned device revealed the following : it is confirmed the unit is leaking from the instrument channel, with scrape marks found inside.Cracks were found in the bending section cover glue.The definitive cause of these issues can not be determined at this time.This report will be updated up completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during a ureteroscopy (urs) and laser lithotripsy using a uretero-reno videoscope the surgeon was having some resistance putting the 2.2fr basket down, after repositioning the scope the physician managed to pass the basket but noted fibers came out from the scope.The physician retrieved one of the fibers then took the rest out of the patient and irrigated the ureter/kidney.There was no patient injury or infection related to this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and to correct information provided on the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the suggested event was caused by handling at the user facility.In addition, it was identified that the subject device was repaired by a third-party agency.In the operation manual, section 3.8 "inspection of the endoscopic system" describes the following as precautions when it is difficult to insert accessories into the biopsy channel: - if significant resistance is encountered and insertion becomes very difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting endotherapy accessories with excessive force may damage the endoscope and/or the endotherapy accessory.In addition, the prohibition of improper repair and modification states that repairs by a third-party agency are excluded from olympus' limited warranty: - this instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result.Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus' own authorized service personnel is excluded from olympus' limited warranty and is not warranted by olympus in any manner.

• 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: 10944490
• MDR Text Key: 219883753
• Report Number: 8010047-2020-09809
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343612
• UDI-Public: 04953170343612
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1