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

Model Number URF-V2

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The urf-v2 video scope, serial number (b)(4) was returned to manufacturer for evaluation due to failing leak test and metal protrusion.The user¿s complaint related to the scope damage was confirmed.The manufacturer performed a visual inspection on the device and found the bending section skeleton protruding out from the bending section cover.The bending section damage was approximately 70 mm from the distal end side, which was also causing a leak on the bending section cover.The bending section cover was removed in order to reveal the extent of the damage to the bending section.Upon removal of the bending section cover, it was confirmed that the bending section skeleton was fully separated producing sharp edges near the insertion tube side.The manufacturer also checked the condition of the bending section support pins, which were not lifted or receding.The instruction manual states the following; ¿do not twist or bend the bending section with your hands.Equipment damage may result¿.The instructions for safe use manual also indicates that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment.This is a newer type ns unit (post counter measure) that was verified by the positioning of the bending section tab; in conjunction with the value (2) of the third digit of the serial number, according to the service center repair work aid.Based on the evaluation, the most probable cause of the bending section skeleton breaking was due to excessive force and/or stress from mishandling.

Event Description

The user facility reported that during reprocessing the endoscope failed the leak test multiple times.The sheath was bent approximately three (3) inches from the distal tip.There was also report of metal protrusion.There was no patient involvement 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: 9104177
• MDR Text Key: 213882770
• Report Number: 8010047-2019-03345
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• 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: 08/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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