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

Model Number URF-V2R

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be conclusively determined at this time.However, use of third-party service provider cannot be ruled out as a contributory factor to the reported event.The device instruction manual warns users that " this instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it; patient or operator injury and/ or equipment damage may result." this report will be updated if new additional information becomes available at a later date.

Event Description

Olympus was informed that during a procedure the distal end of the ureteroscope fell apart inside the patient and it was barely hanging on.There was no patient injury reported.The user facility is reported to be using a third-party service provider for their scope repairs.No additional information was provided regarding the reported event.

• 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: 7290790
• MDR Text Key: 101004277
• Report Number: 2951238-2018-00128
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: URF-V2R
• Device Catalogue Number: URF-V2R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2018
• 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