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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE Back to Search Results
Model Number CYF-5
Device Problem Microbial Contamination of Device (2303)
Patient Problems Unspecified Infection (1930); Urinary Tract Infection (2120)
Event Type  Injury  
Manufacturer Narrative

Olympus followed up with the user facility to obtain additional information regarding the report. The user facility reported that the four patients were cultured and the results were positive for the same microorganism. The user facility claimed that the reprocessing areas were cultured with no growth found. As part of our investigation, an olympus endoscopy support specialist was dispatched to assess the facility's reprocessing practices and provide reprocessing training if necessary. The user facility declined the in-service. The device was sent to an independent testing laboratory for microbiological testing. The testing found no growth of pseudomonas aeruginosa. The device was subsequently returned to olympus for evaluation. The evaluation found residue and debris inside of the biopsy channel and in the channel mount unit. The image was dark and blurry due to black residue noted on the objective lens and on the light-guide lens. The image was fine after the black residue was removed. Additionally, black residue buildup was found on the distal end cover and minor residue build up was found on the bending section cover. There were multiple kinks noted on the biopsy channel at multiple locations throughout the insertion tube and at the bending section area. There was a small cut at 11mm from the distal tip which attributed to a leak at the bending cover. The insertion tube was peeling with nicks and scratches. The exact cause of the reported event cannot be determined. The referenced device was previously returned to olympus for service/repair on 06/12/2012 and a new bending section cover was installed.

 
Event Description

Oca undertook a retrospective review of its mdr files for the period of january 2005 to april 2015. Based upon this review, we are submitting this mdr to separately account for each of the four patients involved in this event. Olympus was informed that after a cystoscopy procedure, four patients developed pseudomonas uti, and sepsis with the same resistant bacteria and resistance profile. The user facility reported that sterilization process was assessed by an unidentified olympus nurse specialist without any issues observed. Please cross reference mfr. Report numbers: 8010047-2013-00064, 2951238-2016-00136, and 2951238-2016-00137 to account for the four patients as referenced in the original report. The following report will be supplemented to cross reference the three associated complaints: 8010047-2013-00064.

 
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Brand NameOLYMPUS OES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTOSCOPE
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 ave.
san jose, CA 95131
4089355161
MDR Report Key5477407
MDR Text Key39600648
Report Number2951238-2016-00135
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 03/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5
Device Catalogue NumberCYF-5
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/25/2013
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2013
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 TREATMENT DATA
Date Received: 03/03/2016 Patient Sequence Number: 1
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