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

Model Number AAS00161-20

Device Problems Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591); Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: aas00180-01, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, the patient sensor triplet cable was not working properly.When the sensor was set up, the 3rd sensor dot would not show up on the screen.When they tried moving the cable connection at the base where the sensor connects to the cable, the yellow dot would flash on the screen and then go away.The navigation was not done because registration could not be completed.The patient was under general anesthesia.There was no patient injury.

Manufacturer Narrative

The system was not returned however the cable was returned and evaluated.There was no evidence that the patient sensor triplet (pst) was malfunctioning.Unable to verify customer complaint.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.If information is provided in the future, a supplemental report will be issued.

• 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 Key: 8702099
• MDR Text Key: 148147210
• Report Number: 3004962788-2019-00046
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521199989
• UDI-Public: 10884521199989
• Combination Product (y/n): N
• PMA/PMN Number: K092365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AAS00161-20
• Device Catalogue Number: AAS00161-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1