MAUDE Adverse Event Report: COVIDIEN COVIDIEN PEDIPORT TROCAR

Model Number 24055

Device Problems Positioning Failure (1158); Component Missing (2306); Defective Device (2588); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/16/2016

Event Type  Injury  

Event Description

One pediport used for a 5mm trocar site (left side) was passed easily but did not deploy its phalanges and it came right back out.Noted that the plastic pieces that bend outward as the phalanges for anchoring were not present on the defective port.It was unclear if they were even on the device to begin with searched for 15 minutes at the time (laparoscopically) and again at the end of the case but did not find any of the small plastic parts.

• Brand Name: COVIDIEN PEDIPORT TROCAR
• Type of Device: COVIDIEN PEDIPORT TROCAR
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 5969770
• MDR Text Key: 55445145
• Report Number: MW5064947
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2016

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: 04/30/2019
• Device Model Number: 24055
• Device Lot Number: J4D0758X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 83