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

Model Number RELTACK4XDPT

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Advance (2524); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

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 parastomal hernia, when fixing above the abdominal wall, the first device was able to use without problems until halfway, but the reload is unable to be exchanged from then.During firing, abdominal sound was generated.A second handle was opened, at first, they used the reloads that is included with the first handle.It was able to be used without problems until halfway, the tack was unable to be placed properly since then.The tack came out only a little from the tip of the cartridge, and it did not come out any more.No abnormal sound was generated from the second handle.They also stopped using the second device and opened a new device to complete the surgery with out problem.The surgical time was extended by less than 30 min.There was no patient injury.

Manufacturer Narrative

Evaluation summary post market vigilance (pmv) led an evaluation of two devices.Visual inspection of both devices noted the timing was disengaged.One partially applied 5dpt device loading unit (dlu) with a tack protruding and disrupted timing was received.No scratches were noted on the inner tube.The handle could be actuated and the unit cycled properly with no dlu attached.Additionally, the articulation knob functioned properly.A test 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 condition could be due to excessive manipulation or to improper loading of the dlu.The root cause of the observed damage was found to be due to the device not being used as intended 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
• MDR Report Key: 8434313
• MDR Text Key: 139307893
• Report Number: 1219930-2019-01628
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K151659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

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: 07/31/2021
• Device Model Number: RELTACK4XDPT
• Device Catalogue Number: RELTACK4XDPT
• Device Lot Number: N8K1075U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR