MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PROTACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 174006

Device Problems Loss of or Failure to Bond (1068); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

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 a laparoscopic totally extraperitoneal procedure, the mesh had been placed and when fixating using the tacker device, only one nail came out after firing for 5 to 6 times and it was noted that it was not firmly fixed.After another 5 to 6 firings, again only one nail came out , which was not firmly fixed and failed to be removed.So the device was continuously used with bilateral hernia until it could not be fired again.After firing a total of additional 4 tacks, the mesh was fixed.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one photograph and one device.A visual and photographic inspection noted no abnormalities.The device was received fully applied.The handle was actuated and able to cycle properly.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The photographic inspection noted no abnormalities.Functional testing could not be performed since the device was not received.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8935827
• MDR Text Key: 155692296
• Report Number: 2647580-2019-04291
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070400
• UDI-Public: 10884521070400
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2019

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 Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P9C1323PY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 09/17/2019; 12/09/2019
• Supplement Dates FDA Received: 10/08/2019; 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 55 YR
• Patient Weight: 54