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

Model Number RELTACK4XDPT

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907); Mechanics Altered (2984); Noise, Audible (3273)

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

Event Date 11/30/2018

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 a laparoscopic intraperitoneal onlay mesh procedure, while the device was being used for the mesh fixation of the abdominal wall, the device did not fire properly and made an unusual harsh sound, the tacks were not coming out.The tacks fell into the patient's cavity, and were able to be retrieved.A new device was used to complete the case.There was no patient injury.

Event Description

According to the reporter, during a laparoscopic intraperitoneal onlay mesh procedure, while the device was being used for the mesh fixation of the abdominal wall, the device did not fire properly, the surgeon had to press the handle 2-3 times to get the tacks out and made an unusual harsh sound tacks were not coming out.After a few minutes of tacking, one tack fell into the patient's cavity, and were able to be retrieved by using a grasper.A new device was used to complete the case.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 a laparoscopic intraperitoneal onlay mesh procedure, while the device was being used for the mesh fixation of the abdominal wall, the device did not fire properly, the surgeon had to press the handle 2-3 times to get the tacks out and made an unusual harsh sound tacks were not coming out.After a few minutes of tacking, one tack fell into the patient's cavity, and were able to be retrieved by using a grasper.A new device was used to complete the case.No injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted no abnormalities.Two partially applied 8dpt single use loading units (sulus) with disrupted timing were received.One partially applied 5dpt sulu with disrupted timing were received.Microscopic inspection noted scratches on the inner tube of all three sulus.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 the scratches on the inner tube and the spur gear damage.The root cause of the observed damage was misuse of the product.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: 8199415
• MDR Text Key: 131504752
• Report Number: 1219930-2018-06870
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

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: 01/31/2021
• Device Model Number: RELTACK4XDPT
• Device Catalogue Number: RELTACK4XDPT
• Device Lot Number: N8D1002X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2019
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 01/28/2019; 02/15/2019
• Supplement Dates FDA Received: 02/01/2019; 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 65