MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC MULTIFIRE VERSATACK* STAPLER W/4.0MM DLU

Model Number 174021

Device Problem Failure to Deliver (2338)

Patient Problem Failure to Anastomose (1028)

Event Date 02/25/2013

Event Type  malfunction  

Event Description

According to the reporter: product would not dispense clips, thus no clips placed into patient.The defective product has been saved for evaluation.

Manufacturer Narrative

(b)(4).

• Type of Device: VERSATACK
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4121383
• MDR Text Key: 4950612
• Report Number: 2647580-2014-00813
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 174021
• Device Catalogue Number: 174021
• Device Lot Number: P0M0091
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/13/2013
• Patient Sequence Number: 1
• Patient Outcome(s): Other