MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC SPACEMAKER BLUNT TIP TROCAR 10MM; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number OMST10BT

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Event Description

Procedure: laparoscopic inguinal hernia repair.According to the reporter: while inserting the pro grip mesh the grey inner seal dislodged and was in the preperitoneal space.The piece was removed without difficulty.Another trocar was used to continue the case without difficulty.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: SPACEMAKER BLUNT TIP TROCAR 10MM
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• 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: 4755131
• MDR Text Key: 5826707
• Report Number: 2647580-2015-00315
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2015

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: 11/30/2017
• Device Model Number: OMST10BT
• Device Catalogue Number: OMST10BT
• Device Lot Number: P4L0460X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 05/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1