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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VHR
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/18/2018
Event Type  Malfunction  
Manufacturer Narrative

The scope was returned to olympus for evaluation. A visual inspection of the device found the bending section cover glue/cement at the distal end side of the insertion tube is cracked, chipped and partially missing exposing the bending section assembly threading. In addition, there is a kink/indentation on the bending section next to the damaged bending section cover glue/cement. The scope passed the leak test. A repair/replacement scope was sent to the user facility. The cause of the reported event could not be conclusively determined, however, based on the evaluation results the damaged glue/cement and kink on the bending section are indicative of user handling. The instruction manual provides warning which states, ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector. Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient. ¿.

 
Event Description

Olympus was informed that during a cystoscopy procedure, parts of the scope around the bending section are flaking off inside the patient¿s bladder. The device fragments were removed from the patient. No patient injury was reported.

 
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Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
408935-512
MDR Report Key7252055
MDR Text Key99937620
Report Number2951238-2018-00089
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberCYF-VHR
Device Catalogue NumberCYF-VHR
Device LOT NumberN/A
OTHER Device ID Number04953170310522
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
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

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