MAUDE Adverse Event Report: COVIDIEN LLC 5MM BLADELESS OPTICAL TROCAR

Model Number ONB5STF

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 01/07/2016

Event Type  Injury  

Event Description

The covidien 5mm bladeless optical trocar with fixation cannula ref #(b)(4) were used to optiview into abdomen at beginning of procedure and none of them would puncture the abdominal wall to get into abdominal cavity.The 5mm trocar is unsafe to enter the abdomen the way these trocars have been lately.It then causes an increase cost to the patient with having to open multiple trocars for one case.Lot #j5j0069x, lot #j5l0847x.The covidien rep was contacted and came in to speak with the surgeon.

• Brand Name: 5MM BLADELESS OPTICAL TROCAR
• Type of Device: 5MM BLADELESS OPTICAL TROCAR
• Manufacturer (Section D): COVIDIEN LLC; mansfield MA
• MDR Report Key: 5587779
• MDR Text Key: 43180471
• Report Number: MW5061787
• 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: 04/15/2016
• 2 Devices were Involved in the Event: 1 2

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: ONB5STF
• Device Lot Number: J5J0069X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2016
• 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: 29 YR