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

Model Number 174006

Device Problem Mechanical Jam (2983)

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

Event Date 01/30/2018

Event Type  malfunction  

Event Description

According to the reporter: occurred during a ventral hernia procedure.The tacking device jammed.There was no patient harm.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The product was received with the timing was disrupted.Additionally, the trigger was jammed.Functional testing was precluded due to the observed condition of the device.A review of the device history record indicates the 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 would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: occurred during a ventral hernia procedure.After one or two tacks were fired the device stuck and when the doctor tried to squeeze the handle the tacking device jammed.In order to solve the issue, a new tacking device was used.There was no patient harm.

• 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: 7265001
• MDR Text Key: 100003726
• Report Number: 2647580-2018-00689
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521070407
• UDI-Public: 20884521070407
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K090470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

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: 10/31/2021
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P6K0218PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 03/30/2018
• Supplement Dates FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• 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