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

Model Number URF-V2

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.The evaluation confirmed the reported scope damage.A visual inspection noted the bending section broken.It was also noted that a sharp metal pin was found protruding through the bending section cover approximately 4mm from the proximal end of the bending section adhesive.In addition, the bending section cover was removed and found the skeleton broken.Foreign materials were also noted.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 user handling and improper maintenance of the device.The instruction manual for use states, ¿do not attempt to bend or twist the endoscope¿s insertion section with excessive force.The insertion section may be damaged.Do not twist or bend the bending section with your hands.Equipment damage may result.¿.

Event Description

Olympus was informed that during an unspecified procedure, the distal end of the scope broke and became severed at the distal point.The bending section unraveled.No protruding wires noted.No device fragment fell inside the patient.The intended procedure was completed with another scope.No patient injury occurred.

• 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: 6404871
• MDR Text Key: 69947533
• Report Number: 2951238-2017-00159
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Device Catalogue Number: URF-V2
• Device Lot Number: N/A
• Other Device ID Number: 04953170343582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Date Manufacturer Received: 02/21/2017
• 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