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

Model Number 174006

Device Problems Break (1069); Physical Resistance (2578)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 bilateral inguinal hernia, the shaft broke with the junction of the fiber body.When the handle was stuck , the doctor took it outside and was releasing the stuck handle with both tacks.The surgical time was extended 30 minutes or more due to the product problem.Used new device in order to complete the case.No injury as a result of the event.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one photograph of a device.The photographs provided by the account shows the shaft disengaged from the handle and the handle tip to be broken.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 may occur if the unit under goes rough handling during use.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.

• 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: 6813014
• MDR Text Key: 83532499
• Report Number: 2647580-2017-06198
• 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: 09/14/2017

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: 04/30/2021
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P6D0175X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• 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: 56 YR
• Patient Weight: 78