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

Model Number 174023

Device Problems Misfire (2532); Human-Device Interface Problem (2949); Mechanical Jam (2983)

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

Event Date 08/10/2017

Event Type  malfunction  

Event Description

According to the reporter, during a hernia repair, the stapler jammed.Initially fired but later the surgeon was not able to squeeze the handle and it stopped firing.The device was difficult to unload.No patient injury noted.No patient suffered from a blood loss or tissue damage.(b)(4).According to the reporter, on the (b)(6) 2017, during a hernia repair, the stapler jammed.No patient was injured, no patient sufferent blood loss or tissue damage and no surgery had extended or time due to damaged stapler.

• Brand Name: MULTIFIRE VERSATACK
• 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 ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6912086
• MDR Text Key: 88136385
• Report Number: 2647580-2017-06982
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521070575
• UDI-Public: 20884521070575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 174023
• Device Catalogue Number: 174023
• Device Lot Number: P7C0534X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2017
• Date Device Manufactured: 03/13/2017
• 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