MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number SDK4000-FT

Device Problems Device Displays Incorrect Message (2591); Application Program Problem (2880); Patient Data Problem (3197)

Patient Problem No Code Available (3191)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, the physician could not get an adequate registration in order to advance to navigation.Something seemed to be interfering with the magnetic field.Did all of the proper trouble shooting and continued to have the same failed result.Registration review never showed the data points within the 3d tree.Finally, a nurse mentioned that the patient had lots of metal in the neck and spine.Did a fluoro shot and confirmed that there were multiple metal rods in the patient's neck and upper spine.The procedure was not completed and was not completed by other means.The patient was under general anesthesia.

• Brand Name: EDGE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; minneapolis, MN 55441 ; 7632104064
• MDR Report Key: 10417993
• MDR Text Key: 203296709
• Report Number: 3004962788-2020-00048
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521545557
• UDI-Public: 10884521545557
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2020

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
• Device Operator: Health Professional
• Device Model Number: SDK4000-FT
• Device Catalogue Number: SDK4000-FT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other