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

Model Number AAS00161-20

Device Problems Device Displays Incorrect Message (2591); Application Program Problem (2880); Data Problem (3196)

Patient Problem No Code Available (3191)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the appropriate device history records of the superdimension console indicates this device was released meeting all quality specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the planning in a procedure, the application was not opening.Computed tomography (ct) had a data issue and could not be opened/ loaded.There was a system error code, "the selected ct could not be loaded because there is not enough free system memory.The planning module will now close and reopen to resolve this issue" and "application has to close".The representative tried deleting older and recent plans, deleting some procedures, and rebooting the system several times.The error still appears after these steps, and they cannot move forward to create a plan.The patient was under general anesthesia for over 90 minutes without a procedure being undertaken.The physician was not able to complete the case and it was not completed by other means.

Manufacturer Narrative

Two ct scans and two photos of the screen were received for investigation.An attempt to load either of the ct scans generated the s ame error as was displayed in the photo received for investigation.This issue is a software anomaly which documents an issue with the software coding.The ct scan was identified in the planning application and divided into 6 sequences, 2 were available for planning.This was because the ct slices were produced with inconsistent intervals.Planning should be completed prior to preparing the patient for the procedure per the system user manual.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.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection of the first photo showed the computerized tomography selection screen, and two sequences were available for planning.Second photo showed an error.It was reported that the patient procedure was aborted or cancelled due to system issue, and there was computerized tomography data issue.The reported issues were confirmed.The most likely cause could not be established from the information available.It was also reported that the application was closing.The reported issue was confirmed.The most likely cause was traced to device design.This was due to the ct slices being produced with inconsistent intervals.Planning should be completed prior to preparing the patient for the procedure per the system user manual.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• 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: 8395808
• MDR Text Key: 137996830
• Report Number: 3004962788-2019-00009
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521199989
• UDI-Public: 10884521199989
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2022

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: AAS00161-20
• Device Catalogue Number: AAS00161-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 02/13/2019; 10/19/2021; 02/04/2022
• Supplement Dates FDA Received: 05/21/2019; 10/22/2021; 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male