MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P7

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, service found the bending section cover and insertion tube were damaged.The bending section cover was perforated by broken metal wires protruding from the inside of the insertion section.In addition, the scope was not water-tight due to perforation of the bending section cover, angulation was insufficient due to elongation of the angle wire, the image guide bundle was significantly broken due to external factors, specified resolution could not be obtained due to damage to the objective lens, a stain was observed in the image due to damage to the image guide bundle, the angle lever was cracked due to external factors, and there were scratches on multiple parts of the device.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

An olympus employee reported a pinhole in the bending section cover of the scope.The subject device was sent to an olympus service center for evaluation.During inspection and testing, service found the insertion tube was damaged and metal wires were protruding.This report is being submitted for the malfunction found during evaluation (protruding metal wires).There was no harm or user injury reported due to the event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to a strong twisting operation to the left and right when the bending section is fixed and an irregular load such as a sudden angle operation.It is recommended that the user facility inspect the device prior to use and on a regular basis continuously.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14278253
• MDR Text Key: 299586505
• Report Number: 8010047-2022-07503
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403811
• UDI-Public: 04953170403811
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181451
• 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: 08/02/2022

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-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2018
• 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