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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI INC. CYSTOSCOPE CYSTOSCOPE AND ACCESSORIES

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GYRUS ACMI INC. CYSTOSCOPE CYSTOSCOPE AND ACCESSORIES Back to Search Results
Lot Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 09/18/2015
Event Type  Injury  
Manufacturer Narrative

The report did not provide a specific model and serial number of the cystoscope and therefore, it is unknown if the device has been returned to olympus for evaluation. The reporter does not mention a specific failure associated with the olympus cystoscope. Olympus is also unable to comment how the patient developed an infection as indicated by the voluntary event report mw5057216. The report does not provide additional information about the patient's case details. The instructions manual provides several warning statements regarding comments associated with third party repairs. "olympus is not liable for any injury or damage which occurs as a result of repairs attempted by non-olympus personnel. Never repair by persons other than olympus-qualified technicians or modify the instrument, as this may result injury of the patient or operator as well as damage to the equipment. These instruments do not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair; patient or user injury and/or equipment damage can result. As repair performed by persons who are not qualified by olympus could cause patient or user injury and/or equipment damage, be sure to contact olympus for repair. ".

 
Event Description

Olympus received a voluntary event report, mw 5057216 that indicates a patient developed an infection after an unspecified procedure where a rigid cystoscope was used to examined the patient's bladder. Detailed information regarding the case, location where the procedure was performed and device information is not avaiable.

 
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Brand NameCYSTOSCOPE
Type of DeviceCYSTOSCOPE AND ACCESSORIES
Manufacturer (Section D)
GYRUS ACMI INC.
136 turnpike road
southborough MA 01882 2104
Manufacturer Contact
donny shapiro
2400 ringwood ave.
san jose, CA 95131
4089355161
MDR Report Key5655438
MDR Text Key45198504
Report Number2951238-2016-00229
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
PMA/PMN NumberUNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2015
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: 05/13/2016 Patient Sequence Number: 1
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