MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC SPACEMAKER STRUCTURAL BALLOON TROCAR; SPACEMAKER BALLOON

Catalog Number OMST10SB

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Event Description

Procedure type: lap inguinal hernia repair.According to the reporter: inner gray seal dislodged when mesh was placed through.

Manufacturer Narrative

(b)(4).

• Brand Name: SPACEMAKER STRUCTURAL BALLOON TROCAR
• Type of Device: SPACEMAKER BALLOON
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC; building 911-67; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy, qa ; 60 middletown ave.; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3850734
• MDR Text Key: 17156808
• Report Number: 2647580-2014-00196
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2014

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: 12/31/2016
• Device Catalogue Number: OMST10SB
• Device Lot Number: P3M0293X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1