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

Model Number URF-V2

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained.The scope was returned to olympus for evaluation.The evaluation confirmed the reported scope issue.Olympus inspected the scope and found the bending section metal tab sharp and protruding out from the bending section cover near the insertion tube side of the scope.Upon removal of the bending section cover, the bending section skeleton was also found broken.The scope was serviced and returned to the user facility.Based on similar reported events and evaluation findings, the cause of the protruding / lifting skeleton metal tab could be attributed to the operator¿s technique.The original equipment manufacturer (oem) performed investigations related to this device issue.As a result, the oem has conducted a field corrective action including a distribution of ¿instructions for safe use¿ to mitigate the potential risk of patient injury.The ¿instructions for safe use¿ provides several warning statements in an effort to prevent equipment damage and patient injury.¿if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient.If the up/down angulation control lever does not move.If the angulation control mechanism is not functioning properly.Visually inspect the bending section for no metallic parts protruding from the bending section.Visually inspect the bending section for bends, twist, or other irregularities while the bending section remains straight.Visually inspect the bending section for abnormal bending shape, or other irregularities.Continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation.".

Event Description

Olympus was informed that during an unspecified event, patient injury occurred.The patient injury is unknown.It was also reported that the scope was found with a broken rib and punctured a hole in the bending section rubber.

• 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: 7118197
• MDR Text Key: 94873352
• Report Number: 2951238-2017-00768
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/17/2017
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/14/2017
• 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
• Removal/Correction Number: Z-1251-2017
• Patient Sequence Number: 1