MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V2

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

E1) establishment name- the second affiliated hospital of zhejiang university school of medicine: noting due to character limit.The device was returned to olympus for evaluation and the customer's allegation was confirmed due to a pinhole on the bending section cover.In addition to the protruding metal wire, evaluation also found that the bending angle in the up direction did not meet the standard value due to wear of the angle wire.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the uretero-reno videoscope was leaking.This occurred during reprocessing; patient was not under sedation.There was no delay and no report of patient harm.The device was returned, evaluated, and a metal braid was found protruding from the inside.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

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, the root cause of the reported event is unable to be determined.However, the cause of the event is likely, due to physical stress, during user handling.It was possible, that broken components of the bending section were rubbed with a-rubber (bending section cover), during user handling.Leading to damage of the a-rubber.The event can be detected, by following the instructions, for use (ifu) section: operation manual chapter 3 preparation and inspection: the event can be prevented, by following the instructions for use (ifu) sections, which state: urf-v2/v2r, operation manual.Important information: please read before use_ precautions: 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.Chapter 4 operation 4.1 warnings and cautions: operation: 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.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17222751
• MDR Text Key: 318104340
• Report Number: 9610595-2023-09474
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/11/2023

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: 06/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2018
• 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