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

Model Number URF-P6

Device Problems Mechanical Problem (1384); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

Device return evaluation was completed.The customer complaint was confirmed.Sagging of the curved rubber (bending rubber manipulation/insertion tube) due to handling factors were found.The curved pipe noted damaged due to external factors.Furthermore, inspection found the forceps plug cap has been scraped off due to external factors.Additionally, the following findings during inspection were noted on the device: play in the right/left (r/l) knob observed due to the collapse of the curved tube due to external factors.Scratches on the insertion tube due to external factors are observed.The curved rubber adhesive is missing.Scratches are found on the operation part due to external factors.Scratches are found on the eyepiece due to external factors.Scratches are found on the grip due to external factors.There are scratches on the angle lever due to external factors.The operating part is cracked due to external factors.There are scratches on the ud angle fixing lever (sp) due to external factors.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer reported with an issue of a-rubber (bending rubber) slack (loose).The issue found during an unknown event.There was no patient harm, no user injury reported.Device evaluation found the forceps plug mouthpiece has been scraped.This report is being submitted for scraped forceps plug cap.(reportable malfunction).

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 (dhr) found no deviations that could have caused or contributed to the loose/sagging insertion tube.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because of the stress exerted on the device from repeated/long-term use.Mishandling of the device or some other external factor may have also caused the problem.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 15201316
• MDR Text Key: 304110817
• Report Number: 9610595-2022-00779
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2013
• 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