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

Model Number SD300LG

Device Problems Application Program Problem (2880); Connection Problem (2900)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(cancelled case) 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 Description

According to the reporter, during procedure, the device lg was not detected or recognized.The physician was not able to complete the enb portion of the case and was not completed by other means.The patient was already under 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: 11146869
• MDR Text Key: 226023199
• Report Number: 3004962788-2021-00004
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521199514
• UDI-Public: 10884521199514
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: SD300LG
• Device Catalogue Number: SD300LG
• Device Lot Number: 511268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2020
• Date Device Manufactured: 08/21/2019
• 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