MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ROTICULATOR ENDO MINI-SHEARS* 5MM INSTR.; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 174309

Device Problems Dull, Blunt (2407); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The patient gender is not available.The patient age is not available.The patient weight is not available.Udi number is not available.

Event Description

According to the reporter, during a thoraco/wedge/segmental resection, the surgeon felt that the device became dull.Looking at the tip of the device, he/she found a space between the blades.The event occurred in use for patient.The procedure was completed with another device.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.No visual abnormalities were noted.The rotation knob functioned without difficulty.The jaws extended and retracted without difficulty.The jaws cut the appropriate test media without difficulty.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• 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: matthew amaral ; 60 middletown ave; north haven 06473 ; 2034926373
• MDR Report Key: 5904611
• MDR Text Key: 53042884
• Report Number: 2647580-2016-00638
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K914752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 174309
• Device Catalogue Number: 174309
• Device Lot Number: P6C0326X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 08/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/09/2016; 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1