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

Model Number OMST10BT

Device Problem Burst Container or Vessel (1074)

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

Event Date 10/17/2014

Event Type  malfunction  

Event Description

The customer reports that the small balloon burst during procedure.Another device was used to complete the procedure successfully, with the lost of the pneumoperitoneum.Additional information received via email: were all pieces of the broken balloon recovered? normally yes, but can't be confirmed.Was there any unanticipated tissue loss as a result of this problem? no.Was there any tissue damage as a result of this problem? no.A.If yes, describe the damage and provide details on how the damage was treated/corrected.B.Was the damage irreversible? was there blood loss of 500cc or more due to the product problem? no.Did any additional blood loss resulting from this product problem require a blood transfusion? no.Was surgical time extended by more than 30 minutes due to the product problem? no.Was any adverse event reported as a result of any delay in surgery? (i.E.An extension of the hospital stay, infection, etc.?) no.How is the patient currently? good.

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: 4270284
• MDR Text Key: 16862867
• Report Number: 2647580-2014-01008
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• 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
• Type of Report: Initial
• Report Date: 10/22/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: OMST10BT
• Device Catalogue Number: OMST10BT
• Device Lot Number: P4D0313X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1