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

Model Number	RELTACK4XDPTSW
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted the sleeve of the tip was disengaged.One partially applied 5dpt single use loading unit(sulu) with proper timing was received.Three 8dpt sulus with a full complement of tacks, proper timing, and the shipping wedge attached were received.Microscopic inspection of the sulus noted scratches on the inner tube of each one, indicating that they were improperly loaded onto the device by the user.Due to the sleeve tip disengagement, the sulus could not be loaded onto the device for functional testing.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The root cause of the observed disengaged tip sleeve condition was determined to be a result of a manufacturing activity.Pressure applied to the distal sleeve afte r the welding process can deform the lances and cause the sleeve to dislodge.A process improvement has been initiated to prevent this condition from recurring.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 surgeon attempted to load multiple tack cartridges onto the handle, but the pins in the shaft would not hold the tack loads onto the shaft.The product was not used in patient.The new device was opened to complete the case.

• 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: 9712860
• Report Number: 1219930-2020-00742
• Device Sequence Number: 3655069
• Product Code: GDW
• UDI-Device Identifier: 20884521726380
• UDI-Public: 20884521726380
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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: 05/31/2021
• Device Model Number: RELTACK4XDPTSW
• Device Catalogue Number: RELTACK4XDPTSW
• Device Lot Number: N8K0310UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1