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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE
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AIRCRAFT MEDICAL LIMITED MCGRATH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE Back to Search Results
Model Number 300-000-000
Device Problems Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); No Code Available (3191)
Event Date 09/17/2019
Event Type  Death  
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during use, the device's screen became foggy.The patient expired.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician and medtronic medical safety confirmed the device did not cause nor contribute to the patients death.
 
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.
 
Event Description
According to the reporter, during use, the device's screen became foggy.The patient expired due to overdose and not related to the device.
 
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.
 
Event Description
According to the reporter, during use, the device's screen became foggy.The patient expired due to overdose and not related to the device.
 
Manufacturer Narrative
Additional information: b2, b3, b5, d9, g3, h1, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the device's screen became foggy.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.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.
 
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Brand Name
MCGRATH
Type of Device
ENDOSCOPIC TISSUE APPROXIMATION DEVICE
Manufacturer (Section D)
AIRCRAFT MEDICAL LIMITED
7 cross way
dalgety bay,fi KY11 9JE
GB  KY11 9JE
MDR Report Key9246455
MDR Text Key164006043
Report Number3010244187-2019-00023
Device Sequence Number1
Product Code OCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number300-000-000
Device Catalogue Number300-000-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2019
Date Manufacturer Received03/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age36 YR
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