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

Model Number	RELTACK3X10SW
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the distal sleeve was disengaged.It was reported that the user was unable to load the reliatack device.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: the lock switch button (blue button) must be in the forward (lock) position upon inserting and removing the device from the trocar.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic ventral hernia repair, the user had difficulty with loading the reload onto the handle.The "push to reload" button was difficult to press.The device was not used on the patient.Another tacker was used to resolve the issue in order to complete the case.There was no patient injury.Medtronic's initial evaluation of the incident device found the distal sleeve was disengaged and missing.Both lock balls were missing.

• 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: 11315075
• Report Number: 1219930-2021-00599
• Device Sequence Number: 16364569
• Product Code: GDW
• UDI-Device Identifier: 10884521726376
• UDI-Public: 10884521726376
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140609
• 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
• Report Date (Section B): 02/11/2021

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: 08/31/2022
• Device Model Number: RELTACK3X10SW
• Device Catalogue Number: RELTACK3X10SW
• Device Lot Number: N9M0750RY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR