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

Model Number RELTACK5RDPT

Device Problems Detachment Of Device Component (1104); Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7645513
• MDR Text Key: 112591781
• Report Number: 1219930-2018-03462
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521202405
• UDI-Public: 10884521202405
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1