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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN VERSAONE OPTICAL TROCAR; LAPAROSCOPE, GENERAL PLASTIC SURGERY
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COVIDIEN VERSAONE OPTICAL TROCAR; LAPAROSCOPE, GENERAL PLASTIC SURGERY Back to Search Results
Model Number ONB5STF
Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2019
Event Type  Injury  
Event Description
During a diagnostic/operative laparoscopy procedure, an optical trocar with fixation cannula was used when entering the abdomen with the scope.Upon entry, the scope and introducer were removed from the trocar sleeve; however the introducer did not come out of the pt with the top of the trocar.When the trocar sleeve was removed, the introducer did not come out with the sleeve.The procedure was converted to an open laparotomy to find the missing trocar piece.All pieces of the trocar were found and removed from pt during procedure.
 
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Brand Name
VERSAONE OPTICAL TROCAR
Type of Device
LAPAROSCOPE, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN
MDR Report Key8755524
MDR Text Key150028594
Report NumberMW5087777
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Model NumberONB5STF
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/01/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age37 YR
Patient Weight98
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