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

Model Number	RELTACK4XDPTSW
Medical Device Problem Codes	Positioning Failure (1158); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic umbilical hernia repair, the surgeon was able to fire the tacks, but unable to fire the last few tacks, approximately 5 tacks.There was also difficulty in loading the reload onto the handle.Another tacker was opened to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9, g1 (mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the timing of the instrument was disengaged.The evaluation found that the articulation knob functioned properly.The handle could be actuated and cycled properly with no single use loading unit (sulu) attached.It was reported that the device did not fire tacks as expected, and there was difficulty in securing the reload on the device; however, the reload was still used for the procedure.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 to improper loading of the sulu.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: ensure that the device is in fire mode and the lock switch button is in the forward position upon inserting and removing the device from the trocar.Retraction of the lock switch button in reload mode will cause the reload to be released and potentially fall into the body cavity.At the end of the procedure ensure that all reloads that are in the sterile field have been accounted for.Appropriate force should be applied to the handle of the device when placing tacks.Excessive force may result in damage to the tissue, device and/or the material being fixated.Prior to tack deployment, ensure that the distal tip of the device is at a right angle to the targeted tissue to facilitate appropriate insertion of the tack.After tack deployment confirm full insertion of the tack into the mesh and/or tissue, the shoulder of the tack should be flush with the surface of the material being fixated.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
• MDR Report Key: 11510196
• Report Number: 1219930-2021-01097
• Device Sequence Number: 3931924
• Product Code: GDW
• UDI-Device Identifier: 10884521726383
• UDI-Public: 10884521726383
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 01/31/2022
• Device Model Number: RELTACK4XDPTSW
• Device Catalogue Number: RELTACK4XDPTSW
• Device Lot Number: N0A0372RY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1