MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO RETRACT* II 10MM INSTRUMENT; SINGLE USE LAPAROSCOPIC HAND INSTRUMENTS

Model Number 176647

Device Problems Unstable (1667); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

Procedure: laparo gyn/others.According to the reporter: prior to use a doctor found the jaw was opened with no problem but could not be closed.Also found its unstable conditions.The jaw seemed to be easily disengaged from the device, operating time not extended.New one was opened to complete the case with no problem.No patient involvement.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Type of Device: SINGLE USE LAPAROSCOPIC HAND INSTRUMENTS
• 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: 4392259
• MDR Text Key: 5429726
• Report Number: 2647580-2015-00016
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K914190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 176647
• Device Catalogue Number: 176647
• Device Lot Number: P3J0040X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1