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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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COVIDIEN LP - SUPERDIMENSION INC EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number SDK4900-FT
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/17/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during the procedure, string like fragments of the working channel were pulled back with the tissue sample when making passes with a competitive forceps tool.The superd portion of the case was completed and there was no patient injury.
 
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Brand Name
EDGE
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 Key9268464
Report Number3004962788-2019-00080
Device Sequence Number19394202
Product Code JAK
UDI-Device Identifier10884521545571
UDI-Public10884521545571
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K151376
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/01/2019
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 NumberSDK4900-FT
Device Catalogue NumberSDK4900-FT
Device Lot Number509575
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/17/2019
Initial Report FDA Received Date11/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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