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

Model Number	RELTACK5RDPT
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2018
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 an abdominal wall hernia procedure, the first cartridge was loaded without incident.The device made a strange noise during firing.Among 29 tacks from the attached cartridge and 25 tacks from the additional reload had been fired, about 15 tacks were misfired.The handle was replaced with new one and the new one worked fine.A part of the device fell into the patient's cavity and was retrieved.There was no patient injury.
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 an abdominal wall hernia procedure, the first cartridge was loaded without incident.The device made a strange noise during firing.Among 29 tacks from the attached cartridge and 25 tacks from the additional reload had been fired, about 15 tacks were misfired.Tacks fell into the patient's cavity and were retrieved with a surgical instrument.The handle was replaced with a new one which worked fine.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.One partially applied 5 days post-transfer (dpt) device loading unit (dlu) with disrupted timing and a tack protruding was received.Microscopic inspection noted scratches on the inner tube of the dlu.The dlu could not be loaded onto the returned device due to the disrupted timing of the dlu.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 single-use loading unit (sulu), indicated by the scratches on the inner tube of the dlu.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.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: 7645513
• Report Number: 1219930-2018-03462
• Device Sequence Number: 2143896
• Product Code: GDW
• UDI-Device Identifier: 10884521202405
• UDI-Public: 10884521202405
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 04/30/2020
• Device Model Number: RELTACK5RDPT
• Device Catalogue Number: RELTACK5RDPT
• Device Lot Number: N7D0646UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 09/12/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/10/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1