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

Model Number URF-P5

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

A user facility reported to olympus that the oes uretero-reno fiberscope has a broken fiber.During a standard service inspection of the customer returned device, angle cord damage was noted.This report is to capture the reportable malfunction found at inspection.There was no patient injury or harm reported.

Manufacturer Narrative

Information has been requested but unknown at this time.The device was returned for investigation.Upon evaluation of the device, angle cord damaged, insertion tube leak, broken dots in image, blurred image and infiltration of internal components were noted.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.

Manufacturer Narrative

Three follow up attempts were made to obtain information from the customer however, no response was received.This follow up report is being submitted to include the device history record(dhr) review and results from the legal manufacturer investigation.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.A root cause was unable to be identified therefore, the cause of the phenomena was not in the product or manufacturing process and it was confirmed that there was no safety issue (frequency is low).It is surmised that angulation failure occurred and the wire was cut off at the time of angle operation due to the following reasons.Angle operation was forcibly performed while the bending part was fixed.Judging from the fact that the connecting tube of the insertion section was damaged, external force was applied to the connecting tube of the insertion section, and the internal components came apart.The instructions for use (ifu) states: inspection of the bending mechanism.Perform the following inspection while the bending section is straight.[warnning] if the movement of the up/down angulation lock and angulation control lever are not smooth, the bending mechanism may be abnormal.In this case, do not use the endoscope, because it may be impossible to straighten the bending section during an examination.[note] even if the up/down angulation lever is returned to a neutral position, the bending section remains a little curving.However, there is no influence in the combination with the ureteroscope sheath dilator (st-u1) and endo-therapy accessories.Inspection for smooth operation confirm that the up/down angulation lock is placed in the free ¿f ¿position.Turn the up/down angulation control lever slowly in each direction until it stops.Confirm that the bending section angulates smoothly and correctly and that maximum angulation can be achieved.Turn the up/down angulation control lever slowly to its straight (neutral)position.Confirm that the bending section returns smoothly to an approximately straight condition.¿ inspection of the angulation mechanism 1.Place the up/down angulation lock in the opposite direction of the ¿f ¿mark into the locked position.Turn the up/down angulation control lever in the ¿u¿ direction until it stops.2.Confirm that the angle of the bending section is roughly stabilized when the up/down angulation control lever is released.3.Confirm that the bending section returns to its straight (neutral) position when the up/down angulation lock is placed in the free position and the up/down angulation control lever is released.Olympus will continue to monitor complaints for this device.

• Brand Name: OES 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: 12647652
• MDR Text Key: 281398658
• Report Number: 8010047-2021-13288
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340307
• UDI-Public: 04953170340307
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

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
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2018
• 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