MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE

Model Number B12LTH

Device Problems Material Puncture/Hole (1504); Resistance, loss of (1534)

Patient Problems Death (1802); Great Vessel Perforation (2152)

Event Date 04/29/2016

Event Type  Death  

Event Description

After insertion of trocar for laparoscopic hernia repair, the pt went into asystole.Cpr was initiated and the case was converted to an open procedure.A laceration was found in the inferior vena cava.Bleeding was controlled by applying direct pressure once the laceration was found but repair was not possible due to location of laceration and because of motion of chest during chest compressions.Continued efforts at resuscitation/stabilization failed.The pt remained in asystole and after 58 minutes, the code was called.Pt expired.Surgeon states trocar punctured inferior vena cava.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE
• Type of Device: TROCAR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; route 22 west; somerville NJ 08876
• MDR Report Key: 5664435
• MDR Text Key: 45475340
• Report Number: 5664435
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B12LTH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2016
• Distributor Facility Aware Date: 04/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR