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

Catalog Number 173019

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/05/2014

Event Type  malfunction  

Event Description

Procedure: lap ventral/incisional hernia.According to the reporter, the tip of the endo peanut dislodged from the shaft of the device during use within the abdominal cavity of the pt.The pt was located and removed from the abdominal cavity.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDO PEANUT 5MM DEVICE (3 PER PACK)
• Type of Device: SINGLE USE LAPAROSCOPIC HAND INSTRUMENT
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4209324
• MDR Text Key: 18546787
• Report Number: 1219930-2014-00837
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2019
• Device Catalogue Number: 173019
• Device Lot Number: M4C03X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1