MAUDE Adverse Event Report: FLEXIBLE SCOPE SMALL DIAMETER VIDEO URETEROSCOPE OLYMPUS

Model Number FS.11036

Device Problem Break (1069)

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

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

During a procedure, the angulation wire broke resulting in a minor procedural delay.The patient was under anesthesia at the time of the incident.There were no reported injuries.Under previous repair, the angulation wire had not been replaced however, the angulation system had been adjusted with new stoppers.Flexible scope small diameter video ureteroscope olympus.Urf-v3r was returned to (b)(4) lab on 9/30/2022 for evaluation.Upon investigation, the lab was unable to determine why the angulation wire may have failed prematurely.However, due to the size of the angulation wire/oem design of the angulation system, it is common for angulation wires to break especially during instances where over exertion or excessive torque may have been applied during angulation.As the wire stopper connection point/solder joint was still intact, it is unlikely that the wire failure was related to the previous angulation adjustment performed by the lab.Repair services ang015 - angulation system overhauled, bnr001 - bending rubber replaced, bic004 - biopsy channel replaced (sm.Diameter), ccv006 - distal head replaced, and int022 - insertion tube replaced-small diameter were performed on the device.The device passed outgoing quality control on 10/06/2022 and was returned to customer.

Event Description

The user facility reported that the angulation wire of flexible scope small diameter video ureteroscope olympus.Urf-v3r broke while in use on a patient during the first case after repair.No injuries were reported, however, there was a minor case delay as they needed to switch scopes to complete the procedure.

• Brand Name: FLEXIBLE SCOPE SMALL DIAMETER VIDEO URETEROSCOPE OLYMPUS
• Type of Device: URETEROSCOPE
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15690724
• MDR Text Key: 306821067
• Report Number: 1527821-2022-00005
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2022

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: FS.11036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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