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

Model Number URF-V2

Device Problem Device Damaged by Another Device (2915)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The investigation is in process.The olympus service center confirmed the reported subject device damage.The bending skeleton was broken at the connecting tube edge and there was a hole with a leak at the bending section cover glue; scope failed leak test.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported during a therapeutic ureteroscopy (urs) to remove a stone, the subject device bending section was heavily damaged due to a shot with a non-olympus laser.A piece of the non-olympus laser fiber broke off and was left in the patient.The intended procedure was cancelled because the stone was too large to be removed.There was no clinically relevant extension of the procedure and no harm to the patient occurred.Another procedure, percutaneous nephrolithotomy, was performed to remove the large stone and the non-olympus device fragment.No harm occurred, the patient is doing well.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to physical stress by the user.Ifu (operation manual) states on cautions of inserting laser probe as below: ¿4.4 using the laser system: caution do not insert the laser probe into the instrument channel while applying an excessive force or bending the bending section.The instrument channel and/or laser probe may be damaged.¿ ifu (operation manual) states on handling of insertion section and bending section as below: ¿important information ¿ please read before use.¦warnings and cautions: warning.Do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable 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.¿ ifu (operation manual) states on the inspection prior to user for bending section as below: ¿3.3 inspection of the endoscope.¦inspection of the endoscope.11 inspect the bending section for bends, twist, or other irregularities while the bending section remains straight.12 inspect the bending section for abnormal bending shape, or other irregularities.¿ ifu (operation manual) states on caution for angulation manipulation as below: ¿4.1 precautions: caution.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.¿ additional ¿instructions for safe use¿ also states on angulation manipulation so as not to cause damage to bending section as below: ¿4.1 precautions: caution.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.¿ 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: 14193140
• MDR Text Key: 294610059
• Report Number: 8010047-2022-06979
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/19/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2017
• 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
• Treatment: NON-OLYMPUS LASER FIBER.
• Patient Outcome(s): Other