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

Model Number	URF-P5
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The equipment was returned unrepaired at the customer request.A supplemental will be submitted if additional information becomes available following investigation.An olympus (b)(6) capa has been opened to manage the actions related to remediation of this late mdr reporting.
Event or Problem Description
The device was returned to the olympus repair center by the customer.During evaluation, the repair center found deterioration of the angulation mechanism due to rust.There was no patient involvement; the reportable malfunction was found during service.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation and lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation the device was returned to the olympus optical de brasil ltda for evaluation.The evaluation confirmed the scope¿s insertion section was cut and the angulation mechanism was corroded due to infiltration.The lm reported that the most probable cause for the reported event is as follows: the cause was corrosion of angulation mechanism.The cause of angulation mechanism corrosion cannot be conclusively specified.It was presumed from the following information that water invaded the scope interior from insertion section breakage.The scope was left as it was, which led to the suggested event.The insertion section was cut.Water entered into the inside of the device.Ifu states how to detect leakage as follows.Mbc was not able to confirm whether the user suggested the event or not.The user handling may have deviated from ifu.Reprocessing: general policy - precautions - be sure to perform a leakage test on the endoscope prior to manual cleaning, and do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism or other malfunctions.The legal manufacturer confirmed via dhr that the subject device was shipped from the factory in accordance with specifications.

• 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: 10943373
• Report Number: 8010047-2020-09807
• Device Sequence Number: 16823199
• Product Code: FGB
• UDI-Device Identifier: 04953170286988
• UDI-Public: 04953170286988
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1