MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC SPACEMAKER BLUNT TIP TROCAR 10MM; SPACEMAKER BALLOON

Model Number OMST10BT

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: hernia repair.According to the reporter, the rubber seal broke off and fell into the abdomen of the patient, together with the mesh delivered through the trocar.All of these parts could be removed from the patient.The product was not resterilized prior to the incident.The product was used on a patient.The patient was not injured or jeopardized.There was no extension of the surgery time by more than 30 minutes, no blood loss of more than 500cc, no extension of the incision by more than 1 inch and no unanticipated tissue loss.

Manufacturer Narrative

(b)(4).

• Brand Name: SPACEMAKER BLUNT TIP TROCAR 10MM
• 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: 4847026
• MDR Text Key: 18185928
• Report Number: 2647580-2015-00434
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K924011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: OMST10BT
• Device Catalogue Number: OMST10BT
• Device Lot Number: P4L0264X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1