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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number SDK4900-FT
Medical Device Problem Codes Application Program Problem (2880); Connection Problem (2900)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 09/03/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).(canceled procedure) out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during procedure, the device's lg was detected as already used.It was the last kit so the physician was not able to complete the enb portion of the case.
 
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Brand Name
EDGE
Common Device Name
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
MDR Report Key12495098
Report Number3004962788-2021-00083
Device Sequence Number3439329
Product Code JAK
UDI-Device Identifier10884521545571
UDI-Public10884521545571
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K151376
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (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) 09/20/2021
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? Yes
Operator of Device Health Professional
Device Model NumberSDK4900-FT
Device Catalogue NumberSDK4900-FT
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/03/2021
Initial Report FDA Received Date09/20/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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