MAUDE Adverse Event Report: COVIDIEN VERSAONE OPTICAL TROCAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number REFONBS5STF

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/19/2019

Event Type  Injury  

Event Description

End of covidien versaone optical trocar with fixation 5mm broke off during insertion into abdomen; ref onb5stf, lot j9h2500jy, exp 07/31/2015.Fda safety report id# (b)(4).

• Brand Name: VERSAONE OPTICAL TROCAR
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9524152
• MDR Text Key: 173043589
• Report Number: MW5091895
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REFONBS5STF
• Device Lot Number: J9H2509JY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR