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

Model Number URF-V

Device Problems Mechanical Problem (1384); Aspiration Issue (2883)

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

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has been returned to olympus medical systems corp.(omsc) for evaluation.During the evaluation by omsc, it was confirmed that there was a hole on the instrument channel at 47 cm from the distal tip of the subject device, and air leak was found at the point.Furthermore, there were shavings piled up inside the instrument channel which clogged the channel.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.Based upon the evaluation, it was concluded that the instrument channel might be shaved due to inserting endo therapy accessory forcibly, and the shavings clogged the instrument channel which caused the reported event.The instruction manual contains several warning statements in an effort to prevent channel damage.¿inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories, causing some parts to become detached and/or causing patient injury." "straighten the endoscope¿s insertion tube as much as possible to avoid damage to the instrument channel while inserting the endotherapy accessory into the channel.¿.

Event Description

Olympus medical systems corp.(omsc) was informed that during a tul (transurethral ureterolithotomy) procedure, a guidewire and a laser probe could not pass through the instrument channel of the subject device.The user replaced the subject device with another device and the procedure was completed.There was no injury associated with this event reported.

• 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 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: 7243322
• MDR Text Key: 99796246
• Report Number: 8010047-2018-00144
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2012
• 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