MAUDE Adverse Event Report: COVIDIEN LLC PROTACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 174006

Device Problems Misfire (2532); Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

Event Description

During laparoscopic hernia surgery while using the protack device (surgical tacker), it was noted to have "misfired".The tack did not fully deploy from the device.The surgeon stated "the device jammed with a tack fired but not released from the shaft, and i had to remove that tack, but the final result patient was not affected.Manufacturer response for surgical tacker, (protack) (per site reporter): none to date.

• Brand Name: PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 6431585
• MDR Text Key: 70785193
• Report Number: 6431585
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2021
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P6H0154PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR