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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-VH
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2018
Event Type  Malfunction  
Manufacturer Narrative

The cystoscope and the broken portion of the bending section cover glue were returned to olympus for evaluation. The evaluation confirmed that portions of the bending section cover glue on the distal end and on the insertion side was missing, the remaining portion of the cover glue was not discolored. The bending section cover (distal sheath) was cracked, peeling, discolored, and dented. The internal channel of the cystoscope was examined with the use of a borescope and there was no sign of missing parts or foreign object inside the channel of the device. The cause of the reported incident cannot be conclusively determined, but user handling cannot be ruled out as a contributory factor to the reported incident.

 
Event Description

Olympus was informed that a portion of the bending section broke off and fell into the patient's bladder. Three small black pieces was observed in the patient's bladder as the cystoscope was being withdrawn from the patient. The three black pieces of bending section cover glue was retrieved from the patient by an unknown means. There was no reported adverse impact to the patient. The patient is reportedly doing well.

 
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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 Key7344014
MDR Text Key103019321
Report Number2951238-2018-00192
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,USER F
Reporter Occupation OTHER HEALTH CARE 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 Received03/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-VH
Device Catalogue NumberCYF-VH
OTHER Device ID Number04953170310461
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/28/2018
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? No Answer Provided
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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