MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number D11LT

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); No Code Available (3191)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent: 7/13/2016 attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is a surgical video available for review? are photos available for review? what is the experience of person who placed the trocar? was it being placed under direct vision from another port? was the abdomen insufflated prior to the trocar being inserted? what was the patient¿s bmi? were there any anatomical anomalies of the patient that may have contributed to the event? is the batch or lot number known for this device?.

Event Description

It was reported that during an appendectomy started by video procedure refers knife failure of the trocar, which did not retract the blade and cut the artery and femoral vein.The patient developed cardiac arrest and the surgery became open.The vessels were sutured and the patient recovered well.

• Brand Name: ENDOPATH XCEL
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 5791701
• MDR Text Key: 49453163
• Report Number: 3005075853-2016-03940
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D11LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention