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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS OCTOPUS EVOLUTION TISSUE STABILIZER; STABILIZER, HEART

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PERFUSION SYSTEMS OCTOPUS EVOLUTION TISSUE STABILIZER; STABILIZER, HEART Back to Search Results
Model Number TS2000
Device Problems Mechanical Problem (1384); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Medtronic received information that during use of an octopus tissue stabilizer, it was reported that during the operation, the fixator and chest support were not firm and was wobbly.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.
 
Manufacturer Narrative
Medtronic received additional information that no component detached.The contact between the base and the sternal expander was loose.Correction h6: device codes (fdd/annex a) and eval code method (fdm/annex b) updated.Additional review of the event and additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
OCTOPUS EVOLUTION TISSUE STABILIZER
Type of Device
STABILIZER, HEART
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer (Section G)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key18932268
MDR Text Key338101719
Report Number2184009-2024-00125
Device Sequence Number1
Product Code MWS
UDI-Device Identifier00643169668911
UDI-Public00643169668911
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTS2000
Device Catalogue NumberTS2000
Device Lot Number2023100277
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/18/2024
Initial Date FDA Received03/19/2024
Supplement Dates Manufacturer Received03/20/2024
Supplement Dates FDA Received04/10/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/06/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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