MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC SPACEMAKER BLUNT TIP TROCAR 12MM; SPACEMAKER BALLOON

Model Number OMST12BT

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

Procedure: unknown.According to the reporter: the balloon could not be inflated, it was tested before surgery and was not used on the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: SPACEMAKER BLUNT TIP TROCAR 12MM
• Type of Device: SPACEMAKER BALLOON
• 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: 4294965
• MDR Text Key: 5196989
• Report Number: 2647580-2014-00979
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K924011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/04/2014

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: 11/30/2016
• Device Model Number: OMST12BT
• Device Catalogue Number: OMST12BT
• Device Lot Number: P3L0359X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1