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

Model Number RELTACK3X10

Device Problems Loss of or Failure to Bond (1068); Failure to Advance (2524); Detachment of Device or Device Component (2907); Noise, Audible (3273)

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, on a laparoscopic hernia procedure, when changing to the second reload during screen fixation, the device made noise and did not release tacks.Another reload was used and worked at first.The tacks were taken out of the patient cavity using permanent instruments and restored.It was stated that the tacks were not fixed and were a little far from the usual.They returned to the second reload and used it.However, they noticed that some of the clips' closure were not complete.They replaced reload to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted no abnormalities.Two partially applied 10r sulus with proper timing were received.One fully applied 10r single use loading unit (sulu) with disrupted timing was received.Microscopic inspection noted scratches on the inner tube of all three sulus.The articulation knob of the instrument functioned properly.The returned 10r sulu with could be loaded onto the returned device.The handle was actuated and it was fired down on test media.The instrument made a clicking and crunching sound and the gear popped during firing.The first tack did not seat properly in the test media and tack hang ups were experienced during the second firing of the reload.The unit was disassembled and damage was noted to the spur gear.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 sulu indicated by scratches on the inner tube of the sulu.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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 mc dermott rd; north haven CT 06473
• MDR Report Key: 8176969
• MDR Text Key: 130789087
• Report Number: 1219930-2018-06732
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521202399
• UDI-Public: 10884521202399
• Combination Product (y/n): N
• PMA/PMN Number: K140609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: RELTACK3X10
• Device Catalogue Number: RELTACK3X10
• Device Lot Number: N7F0077UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR