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

Model Number URF-V2

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to olympus for evaluation.The evaluation confirmed the reported device issue.The control knob (a-lever) was stuck causing the bending section to not bend properly.A visual inspection was performed and found the bending section broken at the insertion tube side.A hole was also found on the bending section cover.The bending section cover was removed and found two contact pins lifting from the bending section skeleton.In addition, there was heavy corrosion found on the bending section skeleton and control body section.The scope was serviced and returned to the user facility.Based on the evaluation results and similar reported events, the cause of the bending section damage is likely attributed to user handling.The instruction manual for use provides warning and caution statements in an effort to prevent scope damage.¿do not attempt to bend or twist the endoscope¿s insertion section with excessive force.The insertion section may be damaged.Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.¿.

Event Description

Olympus was informed that during receipt for inspection, the bending section will not bend.There was no patient involvement with 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: 6652443
• MDR Text Key: 77939842
• Report Number: 2951238-2017-00421
• 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: 06/19/2017

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-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: 06/10/2017
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 06/19/2017
• 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