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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEM CORPORATION OES CYSTONEPHROFIBERSCOPE CYSTOFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 06/05/2015
Event Type  Injury  
Manufacturer Narrative

The device referenced in this report is not available for evaluation. As part of the investigation, an olympus endoscopy support specialist (ess) was dispatched to the facility to observe reprocessing practices and to provide training or in-service. The ess found the facility uses a non-olympus automated endoscope reprocessor and understood that the guidelines for their unit would have to be provided by the manufacturer. The ess completed an in-service and provided training to the facility's staff on the appropriate cleaning and reprocessing method. The exact cause of the reported event could not be conclusively determined at this time. Please cross reference mfr. Report numbers: 2951238-2016-00080, 2951238-2016-00081, 2951238-2016-00082, and 2951238-2016-00083 to account for the five patients involved in this event.

 
Event Description

Olympus was informed that five patients developed bacterial infections after undergoing cystoscopy procedures. The dates of the procedures occurred between (b)(6) 2015. Four out of five patients' urine culture tested positive for pseudomonas. The type of bacteria recovered from the fifth's patient urine culture is unknown. The five patients have since recovered. The facility reported there has been no further recurrence of bacterial infection events and isolated the occurrence to a loaner cystoscope that was used in these five cystoscopies. Patient 1 of 5 tested positive for pseudomonas aeruginosa.

 
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Brand NameOES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTOFIBERSCOPE
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 Key5494231
MDR Text Key40114390
Report Number2951238-2016-00069
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2016
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2016
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 TREATMENT DATA
Date Received: 03/10/2016 Patient Sequence Number: 1
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