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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 SDK4000
Medical Device Problem Code Patient Data Problem (3197)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 04/16/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during a procedure, the patient had lobectomy and it took a long time for the area to check off in registration.Did all to get the lesion and sampled entire area to see if was in tumor to place fiducials.The nodule was pet positive so after an hour of sampling didn't place fiducials because of no confirmation.The patient was under general anesthesia.The superd case was not completed and the case was not completed by other means.
 
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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 Key8558396
Report Number3004962788-2019-00035
Device Sequence Number13544924
Product Code JAK
UDI-Device Identifier10884521545557
UDI-Public10884521545557
Combination Product (Y/N)N
Initial Reporter StateFL
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) 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberSDK4000
Device Catalogue NumberSDK4000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/16/2019
Initial Report FDA Received Date04/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age80 YR
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