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

Model Number URF-V2R

Device Problem Break (1069)

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

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

The service technician confirmed the reported defect as insertion tube near the distal end was cut with exposed, broken and protruding metal mesh wires protruding.As a results the scope failed the leak test.Additionally, the bending section cover was confirmed to be third party repair/parts.The scope was repaired and returned to the customer.A review of the repair history of the scope indicates the scope was last serviced via repair in october 2020 for a leak in biopsy channel and broken bending section.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

Olympus service technician was informed by a biomedical engineer at the user facility that the uretero-reno videoscope needs to be returned for service for a reported ¿the distal end the tube is broken¿ that occurred during reprocessing.The scope was returned to the service center; during inspection and testing, the service technician confirmed the reported defect as insertion tube near the distal end was cut with exposed, broken and protruding metal mesh wires.No patient injury or harm was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, a definitive root cause could not be established.The cause was presumed as below: the concerned area received physical stress from user handling and then became broken.Third party repair was done improperly.The user can properly detect the suggested event by handling the device in accordance with the following instructions for use (ifu): "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 user can reduce/prevent occurrence of the suggested event by handling device in accordance with the following ifu: "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.If the endoscope cannot be withdrawn from the ureteral access sheath smoothly, do not attempt to forcibly withdraw it.Rather, withdraw the endoscope with the ureteral access sheath.Otherwise, patient injury, bleeding, and/or perforation may result.As repair performed by persons who are not qualified by olympus could cause patient or user injury and/or equipment damage, be sure to contact olympus for repair following the instructions given, ¿returning the endoscope for repair¿.¿ 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: 13446247
• MDR Text Key: 295981965
• Report Number: 8010047-2022-02380
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343612
• UDI-Public: 04953170343612
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• 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