MAUDE Adverse Event Report: COVIDIEN VERSAPORT V2 BLADELESS OPT 12; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number ONB12STF

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Great Vessel Perforation (2152)

Event Date 04/22/2015

Event Type  Injury  

Event Description

Procedure: lap stomach bypass.According to the reporter: used product: onb12stf of onb12lgf.Message from hospital to (b)(6) only on (b)(6) 2015.Op date: (b)(6) 2014.During introducing of the first optic 12mm trocar the trocar tip caused an injury of the aorta with bleeding relevant for the circulation.Only by an immediate laparatomy and oversewing of the lesion a lethal exit could be avoid.Sample not available for investigation.Patient had no operation before, no abnormal adhesions.Surgeon did not apply any additional force on the device.Blood loss required a transfusion.Instead of the planned operation a laparotomy was performed to solve the complication.Surgeon was not able to do the planned intervention.Hospital stay probably 1 day more than expected for the planned intervention.Patient stay at home, physical ok mental unknown.The surgeon informed only the insurance at firs.Only when surgeon informed purchase of hospital that he will change optical trocar (from covidien to xcel trocar from j+j), purchase informed swiss medic.It seems that the form and the length of the tip prefers an injury (the tip of j+j trocar is really only half long and has another form than covidien trocars).No further demand/claim from hospital side to covidien.Patient is well according to the circumstances.What is the current status of the patient? patient stay at home, physical ok mental unknown additional information provided by the account (b)(6) informed only the insurance at firs.Only when (b)(6) informed purchase of hospital that he will change optical trocar (from covidien to xcel trocar from j&j), purchase informed (b)(6).It seems that the form and the length of the tip prefers an injury (the tip of j&j trocar is really only half long and has another form than covidien trocars).No further demand/claim from hospital side to covidien.Patient is well according to the circumstances.

Manufacturer Narrative

(b)(4).

• Brand Name: VERSAPORT V2 BLADELESS OPT 12
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4917786
• MDR Text Key: 20444634
• Report Number: 9612501-2015-00416
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K130435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONB12STF
• Device Catalogue Number: ONB12STF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR