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

Model Number AAS00161-23

Device Problems Device Damaged Prior to Use (2284); Application Program Problem (2880)

Patient Problems Oversedation (1990); No Code Available (3191)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.Evaluation summary: medtronic conducted an investigation based upon all information received.On-site service was completed and no problems were found.It was reported that the device had a damaged connector.A related device issue could not be confirmed.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter during a procedure the device had a damaged connector.The procedure was cancelled due to the issue and was not completed by other means.The patient is under conscious sedation.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and four videos were available for evaluation.A review of all four procedure recording videos found the dates did not correlate with the reported event date.On all the procedure recording videos, the troubleshooting wizards of the locatable guide and location board connection kept appearing and disappearing.Analysis of the hardware logs showed the reoccurrence of connection and disconnection events of the location board.Further testing of the actual device found the device software was within specifications.It functioned normally and within specifications.It was reported that the device had a damaged connector.The reported issue could not be confirmed.The most likely root cause could not be established from the information available.The manufacturing records for each device are also 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.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A video and the e lectronic device-use logs were also provided.Visual inspection noted no conditions.There was no visual damage nor defect detected.All four procedure recordings videos were reviewed, however the reported event date did not correlate with the recording¿s date.On all the procedure recording videos, the troubleshooting wizards of the locatable guide and location board connection kept appearing and disappearing.Functional testing found the device functioned normally and within specifications.Analysis of the hardware logs showed the reoccurrence of connection and disconnection events of the location board.It was reported that the patient procedure was cancelled or aborted due to a system issue.The reported issue was confirmed.The most likely cause could not be established from the information available.It was also reported that the system console had a damaged component.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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 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
• MDR Report Key: 10209863
• MDR Text Key: 201016360
• Report Number: 3004962788-2020-00033
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K092365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AAS00161-23
• Device Catalogue Number: AAS00161-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 78