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

Model Number	RELTACK8RDPT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, at the fifth firing during abdominal wall hernia repair, firing was unable to be performed at the middle of tacking, and firing was also unsuccessful even after replacing the cartridge.Several cartridges were replaced, but the result was the same, so the device was unable to be used.The procedure was completed with manual suturing.The surgical time was extended by more than 30 min.There was no patient injury.
Event or Problem Description
According to the reporter, at the fifth firing during abdominal wall hernia repair, firing was unable to be performed at the middle of tacking, and firing was also unsuccessful even after replacing the tacks.Several tacks were replaced, but the result was the same, so the device was unable to be used.The procedure was completed with manual suturing.The surgical time was extended by more than 30 min.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, d10, g4, h3, h6 h3.Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted no abnormalities.One 8dpt dlu with proper timing, a full complement of tacks and the shipping wedge attached was received.Two fully applied 8dpt single use loading unit (sulu) with disrupted timing were received.One fully applied 5dpt sulu with disrupted timing was received.Microscopic inspection noted scratches on the inner tube of two of the sulus received.The instrument made a clicking and crunching sound and the gear popped during firing.The first tack did not seat properly in the test media and tack hang ups were experienced during the second firing of the reload.The unit was disassembled and damage was noted to the spur gear.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition could be due to excessive manipulation or to improper loading of the sulu indicated by the scratches on the inner tube of the sulu and the damage to the spur gear.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: 9702516
• Report Number: 1219930-2020-00694
• Device Sequence Number: 2824798
• Product Code: GDW
• UDI-Device Identifier: 20884521202372
• UDI-Public: 20884521202372
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 06/30/2021
• Device Model Number: RELTACK8RDPT
• Device Catalogue Number: RELTACK8RDPT
• Device Lot Number: N8F0995X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1