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

Model Number 174006

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578); Mechanics Altered (2984)

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

Event Date 05/16/2017

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 laparoscopy, the device was not firing properly.After 3 presses on the handle the clamp becomes jammed and several tacks came out at the same time.Tacks fell into the patient cavity but were retrieved.Another device was used in other to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.There were no visual or functional abnormalities observed during functional analysis.There were no disengaged components and the handle was able to be actuated.The remaining tacks seated properly in the test media.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• 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: 6811722
• MDR Text Key: 83313556
• Report Number: 2647580-2017-06190
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521070407
• UDI-Public: 20884521070407
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

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 Expiration Date: 01/31/2022
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P7A0163PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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
• Patient Age: 66 YR