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

Model Number	TS2000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of this octopus tissue stabilizer, the tissue stabilizer fractured (fixing clip, tower, hook lock).The device was not replaced, customer stated there was no need.It was asked if there were any adverse patient effects; however, this information was unavailable.No damage was noted to the device packaging.It was asked if any part of the tissue stabilizer fall into the patient; however, this information was unavailable.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows the device is broken.Additional visual inspection shows bone wax in some of the pods.Reason for return was confirmed.Conclusion: complaint confirmed for the fractured octopus tissue stabilizer device.Analysis of the returned device showed bone wax in some of the pods and damage to the clamp.After analysis the cause of this complaint could not be determined but is believed to be stress and/or transportation related.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.This unit passed all required testing and inspections during manufacturing.There were no adverse patient effects as a result of this incident.A review of complaints for similar model numbers showed no trends warranting escalation at this time.Trends for issues with this product are reviewed at product quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.Continued from g3 pma / 510(k) #: device is class i exempt.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.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: OCTOPUS EVOLUTION TISSUE STABILIZER
• Common Device Name: 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 Key: 17105497
• Report Number: 2184009-2023-00488
• Device Sequence Number: 19541605
• Product Code: MWS
• UDI-Device Identifier: 00643169668911
• UDI-Public: 00643169668911
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2024
• Device Model Number: TS2000
• Device Catalogue Number: TS2000
• Device Lot Number: 2021010263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown