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

Model Number URF-V2

Device Problem Mechanical Problem (1384)

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

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned to omsc for evaluation.During the evaluation, omsc confirmed the reported event and a pinhole at the instrument channel of the device.Furthermore, it was confirmed that the inside of the control section of the device significantly corroded.No damage was found on the bending section and the angulation wire of the device.Omsc reviewed the manufacturing history of the device and confirmed no irregularity.Omsc concluded that the cause of the reported event was the corrosion in the control section of the device.The corrosion was highly likely caused by solution, which was used during reprocessing of procedures and invaded through the pinhole portion of the instrument channel.Based on the investigation result of the inner surface of the instrument channel, the pinhole possibly occurred due to an insertion of endo therapy accessory by excessive force.

Event Description

Olympus medical systems corp.(omsc) was informed that the angulation control lever of the subject device did not work and the bending section could not be angulated during an unspecified procedure.The device was replaced with same model but another endoscope and the procedure was completed.There was no patient injury associated with this report.

• 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: 8198240
• MDR Text Key: 132378087
• Report Number: 8010047-2018-02565
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2018

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: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1