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

Model Number URF-V2

Device Problem Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation is in progress.Omsc reviewed the manufacture history of the device and confirmed no irregularity.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 Description

Olympus medical systems corp.(omsc) was informed that during an unspecified procedure, the user facility noticed that the bending section of the subject device did not work and they needed to replace the device.The procedure was completed with another device.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device in this report was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation confirmed that there was an abnormality in the angulation operation.The evaluation also confirmed that the coil pipe inside the control section, through which the angle wire slides during angulation operation, was misaligned causing the angle wire movement was restricted.It is surmised that the coil pipe was misaligned because an excessive compressive force was applied to the angle wire during the angulation operation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.On (b)(4) 2018, olympus visited the user facility and received detailed information of the procedure where the event occurred as follows; the procedure conducted in order to remove a calculus in the ureter, and the patient had been developed hydronephrosis before the procedure.A non-olympus access sheath (flexer) and a guide wire were used for the transurethral ureterolithotripsy with the subject device.After the user facility pushed up the calculus into the renal pelvis by water feeding, the distal end of the subject device did not work during advancing the subject device.Since there was an urachal cystis and the ureter was kinked spirally as surrounding the cystis, the user facility experienced difficulty in the insertion of the subject device within the ureter.The user facility noticed abnormality due to the occurrence of the noise on the monitor for the endoscopic view when the user angulated the bending section of the subject device at the kink part.The user facility concluded that further insertion was impossible because the subject device would be broken, and withdrew the subject device from the patient.After withdrawing the subject device from the patient, the bending section of the subject device remained angulated and no noise occurred on the monitor.After that, the user facility was able to straighten the ureter by removing fluid in the cystis with a needle.The intended procedure was completed by performing reoperation on the next day.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7917712
• MDR Text Key: 124671401
• Report Number: 8010047-2018-01884
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1