MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE; FLEXIBLE VIDEO URETERORENOSCOPE, REUSABLE

Model Number URF-V3

Device Problems Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Customer reported with an issue of dry, failed leak test.The issue found during reprocessing.There was no patient harm, no use injury reported.Device evaluation found bending section damaged.The soldered joints exposed (popped out).

Manufacturer Narrative

The subject device was received and evaluated.Device inspection and evaluation found the bending section (a-rubber) leaking.The customer reported issue was confirmed.In addition, the bending section found damaged, the soldered found exposed (popped out).Additionally , the following findings were observed : peeling on a-rubber glue observed.Cracked video connector observed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

Correction to b5 and h10, ¿soldered joints at bending section popped out¿ was reported where as the legal manufacture reviewed the device evaluation and found: the glued cable support to bending tube was detached.Correction to e3, other health care professional was inadvertently selected.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, a definitive root cause could not be determined.However, it is likely that while the distal end was bent, the device was angulated forcibly toward opposite direction.As a result, the cable support was detached.The following is included in the instructions for use (ifu): "inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities." "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.

Event Description

¿soldered joints at bending section popped out¿ was reported where as the legal manufacture reviewed the device evaluation and found: the glued cable support to bending tube was detached.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO URETERORENOSCOPE, REUSABLE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15044120
• MDR Text Key: 298967641
• Report Number: 9610595-2022-00061
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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