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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EDGE CATHETER SYSTEM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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COVIDIEN LP - SUPERDIMENSION INC EDGE CATHETER SYSTEM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number 1925-7
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/22/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device return has been requested but has not yet been received.The lot number is not known.
 
Event or Problem Description
Site reported a string-like fiber from the extended working channel catheter was on the forceps (non-superdimension forceps) while taking biopsy on tissue during a superdimension enb procedure.The site reported nothing was left behind in the patient.There was no report of patient injury, death, or other serious adverse event and nothing was left behind in the patient.
 
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Brand Name
EDGE CATHETER SYSTEM
Common Device Name
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
COVIDIEN LP - SUPERDIMENSION INC
161 cheshire lane, suite 100
plymouth MN 55441
MDR Report Key6490107
Report Number3004962788-2017-05043
Device Sequence Number13785693
Product Code JAK
UDI-Device Identifier10884521581388
UDI-Public10884521581388
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K102604
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1925-7
Device Catalogue NumberSDK4190-FT
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/22/2017
Initial Report FDA Received Date04/13/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SUPERDIMENSION INREACH SYSTEM
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