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

Model Number	URF-P5
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The olympus representative reported on behalf of the customer, the oes uretero-reno fiberscope presented multiple black dots on the image due to multiple dents on the insertion tube of the scope.Additionally, the retroflex angulation up/down movements were not good, and there was mild leakage from the channel.No patient harm reported.During the evaluation of the device, it was noted the bending tube remained angled downwards and stuck because the wire was broken.This report is to capture the reportable malfunction of the bending tube remained angled downwards and stuck because the wire was broken noted at estimation.
Additional Manufacturer Narrative
The device was returned to an olympus service center for evaluation and the reported issues were confirmed.The biopsy channel had leakage, the image had back dots, and the bending section had slow movement.There was burning / melting of the plastic distal end cover around the tip side forceps opening.The operation part had damage.The eyepiece attachment was abnormal.Forceps get caught during insertion and could neither be inserted not removed.The cleaning brush got caught and there was evidence of flooding inside.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported angulation problem.A review of the device history record found no deviations that could have caused or contributed to the reported device problem.A definitive root cause for the reported issue was not established.However, it is probable that the reported issue occurred because of forcible angulation.It was thought that an irregular stress was applied to the a-wire and coil pipe, which was causing an abnormality in the bending components.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu), which state the following: ¿never perform angulation control forcibly or abruptly.Never forcefully pull, twist, or rotate the angulated bending section.Patient injury, bleeding, and/or perforation may result.It may also become impossible to straighten the bending section during an examination.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the reporter.See updated sections b3, b5, e1, e2, e3, g2.
Event or Problem Description
Additional information was received from the reporter.The issue was detected at reprocessing.No patient or procedure involvement.

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Common Device Name: 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: 14637076
• Report Number: 8010047-2022-09679
• Device Sequence Number: 5574891
• Product Code: FGB
• UDI-Device Identifier: 04953170286988
• UDI-Public: 04953170286988
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2022

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
• Operator of Device: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 06/28/2022; 11/03/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/26/2022; 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown