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

Model Number	RELTACK5R
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2017
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 a laparoscopic hernia procedure, the device was jammed on first firing.There were difficulties with loading the reload onto the handle, pressing the 'push to reload' button and navigating the lock and unlock button.Another device was opened with the same lot number and was used successfully.No patient injury.
Additional Manufacturer Narrative
Device evaluation: post market vigilance led an evaluation of one device.The loading unit was received fully fired with disrupted timing.Microscopic evaluation revealed scratches on the inner tube.Functionally, the dlu could not be loaded due to the disrupted timing of the device.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: 7123818
• Report Number: 1219930-2017-10019
• Device Sequence Number: 16446578
• Product Code: GDW
• UDI-Device Identifier: 10884521202412
• UDI-Public: 10884521202412
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140609
• 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): 01/23/2018

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: 09/30/2019
• Device Model Number: RELTACK5R
• Device Catalogue Number: RELTACK5R
• Device Lot Number: N6J0473UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR