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

Model Number URF-V2

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

Customer does not have any additional information to provide.The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that the bending section was broken with metal sticking out.The customer¿s complaint of broken bending section was confirmed.Additionally, it was noted that the distal end rubber insulation was leaking and the drum unit was corroded.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Customer returned the device for an evaluation of bending section breakage.There is no reported harm to any patient.Upon evaluation of the returned device, it was noted that the bending section skeleton was broken with metal sticking out.This medwatch is being submitted for the reportable malfunction of the broken bending section skeleton with metal protruding.

Manufacturer Narrative

This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation.And to correct information provided on the initial report.The following sections were corrected: g2, 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 legal manufacturer's investigation, it was surmised, that excessive force was applied through user manipulation of the bending section, resulting to damage of the bending tube.The instruction manual identifies, the following related verbiage: ¿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¿.The instruction manual identifies the following, additional related verbiage that may reduce/prevent occurrence of the suggested event by device handling: ¿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¿.Olympus will continue to monitor field performance for this device.

• 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: 12775296
• MDR Text Key: 282723050
• Report Number: 8010047-2021-14282
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 10/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• 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