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

Model Number RELTACK4XDPTSW

Device Problems Loss of or Failure to Bond (1068); Failure to Advance (2524); Firing Problem (4011)

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

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, while being applied to the abdominal wall during a laparoscopic umbilical hernia repair, the surgeon fired the device and the tack partially went into the patient¿s tissue but was still engaged in the shaft of the device.Every other tack did the same thing.The surgeon opened different device and finished the case.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of two photographs and one device.The visual inspection of the device noted no abnormalities.One partially applied 8dpt device loading unit (dlu) with proper timing was received.Photographic and visual inspection noted a tack was protruding from the tip of the dlu.Microscopic inspection noted scratches on the inner tube of the dlu.Additionally, two 8dpt dlus with a full complement of staples and proper timing were received.One 5dpt dlu with a full complement of staples and proper timing was received.Microscopic inspection noted scratches on the inner tube of all three dlus.The articulation knob functioned properly.The returned 5dpt dlu 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 two tacks seated properly in the test media and tack hang ups were experienced during the third firing of the reload.The unit was disassembled and damage was noted to the spur gear.The articulation knob functioned properly.The returned dlu could be loaded onto the returned device.The remaining tack deployed and seated properly in the test media.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).However because no sulu was received, it cannot be determined if the disrupted timing is a result of improper loading of a 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 mcdermott rd; north haven CT 06473
• MDR Report Key: 7757451
• MDR Text Key: 116597114
• Report Number: 1219930-2018-04309
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521726383
• UDI-Public: 10884521726383
• Combination Product (y/n): N
• PMA/PMN Number: K151659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: RELTACK4XDPTSW
• Device Catalogue Number: RELTACK4XDPTSW
• Device Lot Number: N7J0588UX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/04/2018
• Supplement Dates FDA Received: 10/02/2018; 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1