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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/30/2018

Event Type  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 celioscopy intervention promontofixation procedure, there were no tacks that were fired normally from the device.When they placed the tackers, it resulted to hemorrhage and an unanticipated tissue loss.This resulted to an extended surgical time.A fixation with the surgical threads was done to complete the case.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.A visual inspection of the first product noted that a tack was protruding from the tip of the device.Additionally, the trigger was jammed.A visual inspection of the second product noted that the timing was disengaged.Additionally, the trigger was jammed.Functionally, the trigger of both instruments was actuated after disassembling the body from the tube.Tacks were jammed in both tubes and did not deploy due to the timing disruption.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of the reported condition is caused by an instrument that has been exposed to excessive force while applying helixes to a surface.If a helix is fired over improper surfaces it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam.The root cause of the observed damage was misuse of the product which 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: 7788614
• MDR Text Key: 117282108
• Report Number: 2647580-2018-04086
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070400
• UDI-Public: 10884521070400
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P8C1090PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2018
• 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 Outcome(s): Required Intervention