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

Model Number URF-V2

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information is not yet available for this event.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Upon testing and inspection, the device cable was cut.Since it was cut, the function could not be tested.Other incidental findings were the insulation rubber coating on distal had a cut, bending section had broken skeleton with lifted pins and fluid invasion, and minor scratches on control body and scope connector.

Event Description

As reported for this event, during an unknown procedure the device was stuck in the patient in a j position.The device was powered off and the angulation cable cut.Once the cable was straightened the device was removed from the patient.The stent remained in the patient longer as this was being performed.The time taken for this is not known.The patient was under anesthesia at this time.There is no reported harm or adverse impact to the patient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h6, and h10.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, the phenomenon likely occurred due to angulation coil misaligns of a-wire inside angulation coil caused a-wire stuck in coil, which led to the ending tube not being able to return to the straight position.A review of the instruction manual identifies the following verbiage, which aids in identifying the phenomenon as detectable: important information ¿ please read before use : never perform angulation control forcibly or abruptly.Never forcefully pull, twist, or rotate the angulated bending section.Patient injury, bleeding, and/or perforation may result.It may also become impossible to straighten the bending section during an examination.Leakage is detectable appropriately by handling the device in accordance with the following ifu.Occurrence of the suggested event might be prevented.Precautions ¿ warning : 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.Occurrence of the suggested event might be reduced/prevented by handling the device in accordance with the following ifu.·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.

• 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: 11563045
• MDR Text Key: 245866676
• Report Number: 8010047-2021-04113
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1