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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORPORATION OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE Back to Search Results
Model Number CYF-5A
Device Problems Hole In Material (1293); Peeled/Delaminated (1454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2011
Event Type  Malfunction  
Manufacturer Narrative

The device referenced in this report was returned to omsc for evaluation. The evaluation confirmed that the bending section rubber of the subject device was partially torn and missing and there was a hole in the bending section rubber. There was a scratch in the bending section rubber and crack in the glue of the bending section. Omsc reviewed the manufacture history of the subject device and confirmed no irregularity. The cause of the missing of the bending section could not be determined, but a strong physical stress may cause the damage. The operation manual has already warns "before each case, prepare and inspect this instrument as instructed below. Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use this instrument and see chapter 10,".

 
Event Description

Olympus medical systems corp. (omsc) performed a mdr retrospective review and found that this report was required. Omsc was informed that after a cystoscopy, the facility noticed that the bending section rubber of the subject device was partially missing and the metal mesh blade covered by the rubber was exposed. The facility reported that they did not know when and where the bending section rubber torn. There was no patient injury reported related to this event.

 
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Brand NameOES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951
ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA 192-8507
Manufacturer Contact
susumu nisihina
2951 ishikawa-cho
hachioji-shi, tokyo 192-8-057
JA   192-8057
42 642 517
MDR Report Key6281946
MDR Text Key65897793
Report Number8010047-2017-01071
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-5A
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/05/2006
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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