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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACMI CYSTOSCOPE

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ACMI CYSTOSCOPE Back to Search Results
Device Problems Device Disinfection Or Sterilization Issue (2909); Material Integrity Problem (2978)
Patient Problem Unspecified Infection (1930)
Event Date 09/18/2015
Event Type  Injury  
Event Description

I received medical procedure that involved a rigid scope to look at my bladder. I acquired an infection after the procedure. I spoke to an acquaintance and the topic of third party repair came up and the fact that no company will validate sterility of any item that is repaired by a third party company only standing behind and validating sterility from the oem. Are these repair companies regulated by the fda and if not why are they allowed to repair medical devices and then be used in medical procedures without being validated for sterility? why as a patient isn't any healthcare provider notifying me that they were using such instrumentation.

 
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Brand NameCYSTOSCOPE
Type of DeviceCYSTOSCOPE
Manufacturer (Section D)
ACMI
MDR Report Key5161820
MDR Text Key28806209
Report NumberMW5057216
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/14/2015 Patient Sequence Number: 1
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