MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.

Catalog Number B12LTH

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Blood Loss (2597); No Code Available (3191)

Event Date 04/29/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Date sent: 6/14/2016.(b)(4).Additional information was requested and the following was obtained: what was the patient¿s position upon entry? supine.Was this the primary port? yes.Was a scope being used for optical insertion? yes.What size scope was being used? 10mm.Was an angled scope being used? no.Was the patient¿s anatomy normal? yes, but small body habitus.How familiar is the surgeon with bladeless trocars and/or the optical entry technique? the surgeon¿s training was completed in 2004 and has been privileged at the account since 2005 and there has never been a reported event such as this until now.What was the entrance point of the trocar? right middle somewhat lateral.Did the surgeon insufflate prior to insertion? no.Please explain the chain of events after the vessel was punctured? cpr was started, then the patient was converted to open.Other surgeons arrived to assist.They could not obtain iv access nor could they repair the laceration.Resuscitation efforts continued for 58 minutes and then they determined the patient was not salvageable.Patient¿s sex, age, and weight? pre-existing conditions? female, (b)(6), hypertension, hyperthyroidism and hypercholesterolemia.Was an autopsy performed? if so, is a copy available for review? no.Was the device reprocessed? no.Is the surgeon willing to have a peer to peer conversation with ethicon medical safety officer? no.

Event Description

• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5723698
• MDR Text Key: 47360032
• Report Number: 3005075853-2016-03311
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B12LTH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death