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

Model Number CYF-V2R

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the reported user's experience could not be conclusively determine at this time.The instructions for use warns users: if the angulation control mechanism or any other part of the system is not functioning properly, stop the procedure immediately and place the up/down angulation lock in the free "f " position.Then carefully withdraw the endoscope while observing the endoscopic image.If the endoscope cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it; leave it inside the patient and immediately contact olympus.Forcibly withdrawing the endoscope may cause patient injury." if additional information is received or if the device is returned at a later time, this report will be supplemented.

Event Description

Olympus was informed that during a diagnostic cyctoscopy procedure, the physician was about to view the bladder when the bending section became irreversibly locked while inside the patient's urethra.As the physician began flexion of the device, a "snap" was heard and the bending section continued to flex and would not return to the straight position.It was reported that the device was stuck inside the patient for close to two hours.The insertion tube was manually cut in half to release the flexion and allow for removal of the device from the patient.There was no patient injury reported, just minor bleeding.The physician aborted the procedure and did not continue after the scope was removed.No additional information was provided.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5324811
• MDR Text Key: 34287182
• Report Number: 2951238-2015-00630
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2015

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: Physician
• Device Model Number: CYF-V2R
• Device Catalogue Number: CYF-V2R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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