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

Model Number 174006

Device Problems Failure To Adhere Or Bond (1031); Physical Resistance (2578); Mechanics Altered (2984)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturer reference number: (b)(4) this event was originally reported on a quarterly summary report and is being resubmitted per fda request.

Event Description

According to the reporter: occurred during a laparoscopic bilateral inguinal hernioplasty.While tacking mesh to the muscle, the handle of the device becomes stuck after squeezing the tacker.The handle became stuck in the depressed position and was not able to retract back with a single hand while inside the trocar.The surgeons wanted to take the tack out and release the handle with both hands which sometimes causes the tack to misfire outside or damages the handle or breaks the shaft.Additionally, once the tack is fired the subsequent tack also pops out and hooks onto the fired tack.When surgeon attempts to remove the tacker from the tissue, the tack gets hooked on the mesh and tears it.These issues caused an extension in surgical time of greater than 30 minutes or more because the surgeon had to spend the time to release the handle, or when the tack gets caught in the mesh he has to slowly and carefully detach the shaft from the tissue.The incision was extended due to the product problem, but not more than one inch.The tacker was replaced with one of a different lot.Patient status is alive, no injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of three devices.The visual inspection of the returned product noted all three units had disrupted timing.The first unit handle was actuated and eleven tacks deployed but did not seat properly.The other two units were jammed, the shafts were removed, and then the handles 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 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.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: 6813204
• MDR Text Key: 83533789
• Report Number: 2647580-2017-06202
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521070407
• UDI-Public: 20884521070407
• 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: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P6E0293X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• 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
• Patient Age: 67 YR
• Patient Weight: 72