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

Model Number URF-P6

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 7 years since the subject device was manufactured.Based on the results of the legal manufacturer¿s investigation, the scrape on the forceps stopper mouthpiece was likely due to stress applied during use, external factors, or handling of the device.However, a definitive root cause could not be determined.During inspection and testing, service confirmed the customer¿s reported leak, due to holes in the bending section cover.A leak was also observed due to a crushed tip cover, which was caused by external factors.The insertion tube was damaged in the bending section due to external factors.The image guide bundle was severely broken due to external factors.The adhesive of the bending section cover was chipped.There was rattling in the control section.The grip had scrapes due to external factors.The instrument channel port was shaved due to external factors.Scratches were observed on the diopter adjustment ring, up/down plate, angle lever, grip, eyepiece section, and insertion tube, due to external factors.Per the legal manufacturer, these other device issues identified by service have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported there was a leak from a pinhole in the bending section cover (a-rubber) of the subject device.There was no patient or user injury reported due to the event.The device was returned to an olympus service center for evaluation.During inspection and testing, service found the forceps stopper mouthpiece was scraped.This report is being submitted for the malfunction found by service during the device evaluation [forceps stopper mouthpiece scraped].

Manufacturer Narrative

Additional information: h9.

• 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: 15171913
• MDR Text Key: 304971686
• Report Number: 9610595-2022-00644
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• 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,User Facility,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1263-2022
• Patient Sequence Number: 1