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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COGENTIX MEDICAL INC ENDOSHEATH CF-2.1 PROTECTIVE BARRIER CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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COGENTIX MEDICAL INC ENDOSHEATH CF-2.1 PROTECTIVE BARRIER CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number CF 2.1
Device Problem Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2016
Event Type  Malfunction  
Event Description

Cystoscope was removed from the sheath and wetness was seen on the scope. This is an indication that there was a breach in the sheath somewhere. Scope was flagged and sent to reprocessing to be sterilized. No harm was caused to the patient as the scope itself had been reprocessed with low-level disinfectant between patients and sterilized prior to being put in use. Manufacturer response for cognetix cystoscope sheath, (brand not provided) (per site reporter): unknown.

 
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Brand NameENDOSHEATH CF-2.1 PROTECTIVE BARRIER
Type of DeviceCYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
COGENTIX MEDICAL INC
135 flanders rd
westborough, MA 01581
MDR Report Key5846292
MDR Text Key51161577
Report Number5846292
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/26/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2016
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCF 2.1
Device Catalogue Number08-4101
Device LOT NumberL1051816
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2016
Device Age1 dy
Event Location AMBULATORY SURGICAL Facility
Date Report TO Manufacturer07/26/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/04/2016 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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