MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VIDEOSCOPE "URF-V"; URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Event Description

The videoscope "urf-v" was returned as part of the asset return process.During routine inspection of the device by olympus, the connecting tube was extremely damaged.There was no procedural or patient involvement associated with this event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the following: the connecting tube had a leak, the distal end was burned, the bending section cover glue was chipped, the connecting tube coating was peeling off, the universal cord was scratched, and the image tilt/upright alignment-lacked angle.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the damaged connectome tube was unable to be identified.The event can be prevented by following the instructions for use which state: ¿¿warnings and cautions¿ ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope 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.¿ olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE "URF-V"
• 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: 17118743
• MDR Text Key: 317328635
• Report Number: 9610595-2023-08769
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2012
• 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