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

Model Number OMST10SB

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/20/2014

Event Type  malfunction  

Event Description

Procedure: hernia.According to the reporter: rubber gasket of trocar dislodged from trocar into patient.Current patient status: good did the difficulty result in unintended colostomy, formal laparotomy, re-operation? no there was no unanticipated tissue loss, no unanticipated ext.Of incision more than 1 inch, no unanticipated blood loss of more than 500cc and no delay over 30 minutes.Device fragment or component falling into patients cavity.Yes device fragment left in patient? no if applicable, when was done to correct this condition? gasket was removed laparoscopically and new trocar was opened.Post-op diagnosis: good.Additional information received via email.What is the lot number for this device? the lot number is not available.

Manufacturer Narrative

(b)(4).

• Brand Name: SPACEMAKER STRUCTURAL BALLOON TROCAR
• 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: 4338217
• MDR Text Key: 5177760
• Report Number: 2647580-2014-01058
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2014

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 Model Number: OMST10SB
• Device Catalogue Number: OMST10SB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1