MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK3X10
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter during a laparoscopic incisional hernioplasty procedure when applying the tacks on the mesh, both device had difficulty loading the reload onto the handle and reload was not securely fastened onto the shaft.It was noted that in one of the device, none of the tacks was able to be fired normally from the device.The surgical time was 30 minutes or more due to the product problem.Another device was used to resolve the issue.
Additional Manufacturer Narrative
D10 concomitant product: reltack3x10 - reltack3x10 reliatack articulat reload a, lot# n2a0075y 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Microscopic inspe ction of the single use loading unit (sulu) noted cracks on the inner tube.It was reported that there was difficulty in securing the reload on the device; however, the reload was still used for the procedure and upon loading, the reload was not seated properly and/or wobbled with movement of the device.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues can occur due to excessive manipulation or improper loading and unloading of the sulu.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.The instructions included with this device provide the following guidance: instructions for loading: do not attempt to remove the shipping wedge until the reload is locked and loaded onto the instrument.Ensure the device is in reload mode, red toggle button exposed, and the device is in the straight (unarticulated) position.To load the reliatack¿ device select the appropriate reload, then pull and hold the blue lock switch button, located on top of the instrument, in the back position.Insert the pin located at the distal end of the shaft into the reload.Ensure that the arrow on the shaft is aligned with the arrow on the reload.Push the reload onto the distal end of the shaft until the two arrows meet.Release the lock switch button allowing it to return to the forward position.Gently pull on the reload to confirm that the device is properly loaded.Remove the shipping wedge once the reload is properly locked and loaded.Instructions for unloading: push the left side of the toggle button to expose the red portion of the button and ensure that the device is in the straight (unarticulated) position.Pull and hold the blue lock switch button, located on top of the instrument, in the back position.Pull the reload off of the shaft of the device.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: RELIATACK
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17148889
• Report Number: 1219930-2023-02519
• Device Sequence Number: 12198575
• Product Code: GDW
• UDI-Device Identifier: 10884521202399
• UDI-Public: 10884521202399
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K140609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: 08/31/2025
• Device Model Number: RELTACK3X10
• Device Catalogue Number: RELTACK3X10
• Device Lot Number: N2L0331Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Male