MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN-MFG RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK5R
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device Difficult to Setup or Prepare (1487); Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic ventral hernia repair, while fixating the mesh, there were difficulties with loading the reload onto the handle although the reload securely fastened onto the shaft.The reloads were not able to load properly due to misalignment of the reload and the flat head tip of device handle.Some tacks could not be fired, and were only able to be fired after some difficulty.To resolve the issue, more tacks were opened but some tacks were not able to fire.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.Three 5r fully applied device loading unit (dlu) were received with disrupted timing.Microscopic inspection on all three dlus noted scratched on the inner tubes.All dlu were unable to be loaded onto the returned device due to the disrupted timing.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 conditions could be due to improper loading of the reloads, indicated by the scratches on the inner tube of the reloads.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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 NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7129716
• Report Number: 1219930-2017-10180
• Device Sequence Number: 13902885
• Product Code: GDW
• UDI-Device Identifier: 10884521202412
• UDI-Public: 10884521202412
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K140609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 11/30/2019
• Device Model Number: RELTACK5R
• Device Catalogue Number: RELTACK5R
• Device Lot Number: N6L0059UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1