MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC VERSPRT*RPF 10MM-15MM TCR W/100MM RAD SL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 179078

Device Problems Difficult to Insert (1316); Physical Resistance (2578)

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

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the device did not work properly because not opened the skin of patient.According notifier, no injury.No permanent damage.There was no excessive bleeding.There was no increased surgical time.There was no increased hospitalization.

• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 5226747
• MDR Text Key: 31569243
• Report Number: 2647580-2015-00809
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 179078
• Device Catalogue Number: 179078
• Device Lot Number: P3C0470X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1