MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO PADDLE RETRACT* 12MM INSTRUMENT; RETRACTOR

Model Number 173046

Device Problems Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)

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

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a laparoscopic nissen fundoplication, the instrument was inserted into abdomen via a trocar for laparoscopic use but it did not deploy and the blue paddle cover somehow became separated from the metal frame and had to be retrieved.

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, engineering review of the product and an evaluation of the returned device.The tube assay or introducer was observed bent at the tip area.The bands were observed bent or deformed.No additional anomaly was observed on the instrument.The instrument was functionally tested and the paddle open and close as per intended design.Unit was verified in details and no missing part was found.The unit was assembled with all its components.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.Engineering determined that replication of the reported condition may occur as a result of the device being subjected to excessive force.The tube assembly or introducer and the blue bag were broken during usage.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Type of Device: RETRACTOR
• 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: 5410335
• MDR Text Key: 37521943
• Report Number: 2647580-2016-00049
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 173046
• Device Catalogue Number: 173046
• Device Lot Number: P5H0683X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 64