MAUDE Adverse Event Report: COVIDIEN PEDIPORT LOCKING TROCAR 5.5MM

Model Number 24055

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/11/2016

Event Type  Injury  

Event Description

Pediport trocar extendable middle sleeve broke inside abdominal cavity intraop.All pieces removed.

• Brand Name: PEDIPORT LOCKING TROCAR 5.5MM
• Type of Device: PEDIPORT LOCKING TROCAR 5.5MM
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 5929544
• MDR Text Key: 54042712
• Report Number: MW5064560
• Device Sequence Number: 1
• Product Code: DRC
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 77 YR
• Patient Weight: 56