MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION HD FLEXIBLE CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problems Degraded (1153); Material Disintegration (1177)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

Olympus was informed that after the completion of a diagnostic cystoscopy procedure, it was observed that tissue fibers were coming out of the tip of the scope at the distal end.It was also reported that some of the distal end cover glue had fallen into the patient and was not retrieved by the physician.The physician believed that the device fragments will be flushed out naturally.There was no patient injury reported and intended procedure was completed using same device.It was further reported that during previous cleaning of the device there were several pieces of the black adhesive at the distal end of the device missing.No further information has been provided.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The evaluation confirmed that a portion of the bending section cover glue was missing from the distal end causing the device to fail leak test.This type of damage is most likely due to either improper handling or damage that can occur during reprocessing.The device was serviced and returned to the user facility.

• Brand Name: HD FLEXIBLE CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCO
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4749181
• MDR Text Key: 5770871
• Report Number: 2951238-2015-00220
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/17/2015

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: CYF-VH
• Device Catalogue Number: CYF-VH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 05/04/2015
• 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