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 Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

Procedure: colectomy.According to the reporter: the balloon could not be inflated by injecting the air in it.Operating time not extended.New one was opened to complete the case with no problem.No patient harm.The patient current status: good tissue damage: no.Nothing fell into the cavity.No bleeding.No info of lot# is available.In case lot# is identified after arrival of sample, i will add it on cts.Confirmed that the clinical sample is being returned for investigations.When it is returned to the investigator of manufacturer : unknown nothing of adverse event caused by extension of operating room time was reported."no patient info is available: gender: unknown, age: unknown, weight: unknown / the customer did not know if reinforcement material was used.".

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: 4343306
• MDR Text Key: 17997476
• Report Number: 2647580-2014-01061
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 11/21/2014

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: OMST12BT
• Device Catalogue Number: OMST12BT
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1