Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number AAS00161-12
Device Problems Device Displays Incorrect Message (2591); Application Program Problem (2880)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/23/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during procedure, the device had a system error code/message.It was reported that the location board was not connected and all cords were secure.The surgeon could not navigate or complete the case because the location board was showing as not connected.The physician was not able to complete the enb portion of the case and was not completed by other means.The patient already under anesthesia when the issue happened.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUPERDIMENSION
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
COVIDIEN LP - SUPERDIMENSION INC
161 cheshire lane, suite 100
plymouth MN 55441
MDR Report Key11505969
MDR Text Key240594647
Report Number3004962788-2021-00021
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K151376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAAS00161-12
Device Catalogue NumberAAS00161-12
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
-
-