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

Model Number URF-V2

Device Problems Material Protrusion/Extrusion (2979); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

A user facility returned the olympus, model urf-v2, uretero-reno videoscope to olympus for repair due to a report of air/water leakage.There was no patient injury, associated with the problem, reported to olympus.Upon inspection and testing of the returned device, it was determined that the bending rubber was damaged and metal noted protruding.This report is submitted due to the finding that the bending rubber was damaged and metal protruding.

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the bending rubber was torn and metal was protruding.Additional evaluation findings are as follows: 1.) a-rubber leak; 2.) insertion tube defects; 3.) fluid invasion with no leakage; 4.) coating on the universal cord peeling.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

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.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, it was likely that the device was pushed with excessive force while the bending tube was being bent, causing the tube to break.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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.¿ ¿do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.¿ this supplemental report includes information added to event and device manufacture date.Also, this supplemental report includes a correction to the initial report.Usage of device changed from ¿unknown¿ to ¿reuse.¿ olympus will continue to monitor field performance for this device.

Event Description

The following additional information was received regarding the reported event: the event date is unknown.The defect was found during sterilization of the device.The device had been used to complete a ureteroscopy (urs) with stone extraction procedure.There was no patient injury or harm.

• 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: 14603273
• MDR Text Key: 301770884
• Report Number: 8010047-2022-09486
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• 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