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

Model Number URF-V2R

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.The evaluation confirmed that reported device damage.The bending section and angulation were found damaged.The scope was serviced and returned to the user facility.Based on the evaluation findings, the cause of the reported scope damage is likely attributed to the operator¿s technique / excessive force.The instruction manual for use states, ¿to prevent damage, do not apply excessive force to the endoscope and accessories during reprocessing.Do not attempt to bend or twist the endoscope¿s insertion section with excessive force.The insertion section may be damaged.¿.

Event Description

Olympus was informed that during reprocessing, it was noted that there was a bend (kink) above the metal near the tip of the scope.

• 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: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6415643
• MDR Text Key: 70327708
• Report Number: 2951238-2017-00167
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2017

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-V2R
• Device Catalogue Number: URF-V2R
• Device Lot Number: N/A
• Other Device ID Number: 04953170343612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/17/2017
• 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