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

Model Number	URF-P5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to olympus medical systems corp.(omsc) but was returned to (b)(4) for evaluation.(b)(4) inspected the device and confirmed the following; the angulation from the neutral position was out of specification due to the broken angle wire.The body control unit and grip unit were contaminated.The instrument channel port was corroded.A dot was displayed on the endoscope screen due to damage to the image guide bundle.The focus could not be adjusted well due to the damage of the diopter adjustment ring.There was a leakage at the bending section rubber due to a pinhole.There was a leakage at the channel due to breakage.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus inspected the device at the service department of olympus (b)(4) and found that the bending section kept angulated, due to the broken angle wire causing the end to come apart.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the withdrawal of mfr report #8010047-2021-03285 and correct the initial report.Based on the device inspection result provided by olympus korea co., ltd., olympus medical systems corp.(omsc) determined that the bending section of the device was not locked with it is bent.Therefore, omsc concluded that the correct phenomenon is insufficient angulation due to the elongation of the angle wire.Based on the above information, olympus re-evaluated the event reported in the initial report and determined that the failure mode is not a mdr reportable malfunction.If additional information becomes available, this report will be supplemented.

• 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
• MDR Report Key: 11409981
• Report Number: 8010047-2021-03285
• Device Sequence Number: 3882457
• Product Code: FGB
• UDI-Device Identifier: 04953170316593
• UDI-Public: 04953170316593
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: No Information
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1