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

Model Number URF-P6R

Device Problems Image Display Error/Artifact (1304); Mechanical Problem (1384)

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

Event Date 01/12/2019

Event Type  malfunction  

Manufacturer Narrative

The evaluation by(b)(4) also confirmed that there was no remarkable dent on the device.Furthermore, there was no air leakage of the device and there was no trace of liquid infiltration into the control section.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 is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that black spot appeared on the endoscopic image of the subject device during a therapeutic procedure while the device was inside the kidney of patient.The device was replaced with other device and the procedure was completed.There was no report of patient injury associated with the event.The device has not been returned to omsc but was returned to olympus medical systems (b)(4).The evaluation at the repair center of (b)(4) confirmed that the angulation of the bending section of the device was locked in down direction.

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.Omsc evaluated the subject device and confirmed that the movement of the angle wire was restricted due to the deformed coil pile that covers the angle wire.It is surmised that the coil pipe was deformed because an excessive compressive force was applied to the distal end of the bending tube.However, the exact cause of the reported event could not be conclusively determined.

• Brand Name: 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
• MDR Report Key: 8313455
• MDR Text Key: 137001132
• Report Number: 8010047-2019-01031
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

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-P6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1