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

Model Number URF-V

Device Problems Material Frayed (1262); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The reported complaint was confirmed.A visual inspection of the device noted two critical abnormalities on the scope.A severe kink was noted on the bending section measuring at 5.2 cm from the distal end.Another severe kink with a gap was noted on the insertion tube measuring 16 cm from the distal end of the protector unit.A microscopic investigation of the insertion tube noted a gap on the insertion tube sheath measured at 3 mm, exposing the skeleton and the internal elements.Foreign materials were noted on the skeleton.The reported phenomenon is most likely attributed to excessive force due to physical damage.The instruction manual states: ¿prior to sterilizing the fiberscope, the venting cap must be attached.Oes fiberscopes are completely sealed to make them watertight.Failure to attach the venting cap will prevent the air sealed inside the fiberscope from escaping as a vacuum is created within the sterilization chamber.This will cause the rubber covering the bending section to rupture.After the ethylene oxide (eto) procedure is completed, the venting cap must be removed in order to reseal the fiberscope and insure watertightness.¿.

Event Description

Olympus was informed that during the reprocessing of the uretero-reno videoscope post an unspecified procedure, it was noted that the sheath was torn and the wires were exposed protruding from the bending section.The procedure was completed with the same device.No patient injury was reported.

• 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: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5686428
• MDR Text Key: 46207145
• Report Number: 2951238-2016-00464
• 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: 05/27/2016

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-V
• Device Catalogue Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 05/27/2016
• 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