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

Model Number AAS00161-20U

Device Problems Defective Device (2588); Application Program Problem (2880)

Patient Problem No Code Available (3191)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, there was an issue with the lb cable.The superd portion of the case was not completed.It was not completed by other means as well.The patient was under anesthesia.

• Brand Name: SUPERDIMENSION INREACH SYSTEM
• 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: 10273175
• MDR Text Key: 198847221
• Report Number: 3004962788-2020-00035
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/14/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: AAS00161-20U
• Device Catalogue Number: AAS00161-20U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other