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

Model Number 174006

Device Problems Detachment Of Device Component (1104); Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

User facility listed in initial reporter.(b)(4).This event was originally reported on a quarterly summary report and is being resubmitted per fda request.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter during a lap inguinal hernia with tapp, the surgeon used the device to fix the mesh and close the peritoneum flap.The first device jammed.A second device was opened which all jammed after firing 4-5 tacks.In trying to work with the device, it damaged the piece also.He ended up closing the peritoneum flap with suture.Tacks fell into the patient cavity but were retrieved with meriland.Surgical time was extended by more than 30 minutes.There was an issue with packaging as it used to be a blister package but now it does not have blister packaging.Patient is alive with no injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the returned product noted the unit was returned disassembled.The second unit was received with disrupted timing and a jammed handle.The shaft was received removed from the handle.The handle was actuated and cycled 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.Replication of the jammed unit 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.Replication of the disassembled unit may result from rough handling of the unit during use.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.No enhancements or improvements were generated for the reported condition.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.

• 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: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6811245
• MDR Text Key: 83276715
• Report Number: 2647580-2017-06174
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070400
• UDI-Public: 10884521070400
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K090470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• 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: P6G0408PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• 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: 52 YR
• Patient Weight: 78