MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO PEANUT* 5MM DEVICE (3 PER PACK); SINGLE USE LAPAROSCOPIC HAND INSTRUMENTS

Model Number 173019

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/03/2014

Event Type  malfunction  

Event Description

Procedure: hernia.According to the reporter: the endopeanut dislodged in the patient.

Manufacturer Narrative

(b)(4).

• Type of Device: SINGLE USE LAPAROSCOPIC HAND INSTRUMENTS
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4168882
• MDR Text Key: 4870163
• Report Number: 1219930-2014-00942
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2019
• Device Model Number: 173019
• Device Catalogue Number: 173019
• Device Lot Number: M4F05X
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1