MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT DILATING 12X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number 2D12LT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Perforation of Vessels (2135); Blood Loss (2597); No Code Available (3191)

Event Date 03/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent: 11/3/2015.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what is the exact product? excel endopath dilating tip trocar.Was it a dilating tip or bladeless trocar? see above.If it was bladeless, what degree of scope was used? what was the issue with the trocar? the ivc was perforated.Do not know exact issue.The device has been sent to ecri for an independent evaluation.Who was using the device? surgeon what was their experience? 15 plus years what is the current status of the patient? recovered.

Event Description

Per user facility medwatch form, #mw5044440, during an elective robotic assisted hysterectomy converted to exploratory laparotomy for vascular repair and subsequent abdominal hysterectomy procedure; following insufflation to 20 mmhg, a sharp 12mm disposable trocar and sleeve was placed intra abdominally.It was immediately noted that there was active bleeding in the area of the ivc.A puncture was discovered in the ivc and in the right anterior common iliac artery.Both were repaired uneventfully and the planned procedure surgery (hysterectomy) was completed without further complication.It is not known whether or not the device is available for return.

• Brand Name: OPT DILATING 12X100 STABILITY
• 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: 5198719
• MDR Text Key: 30312469
• Report Number: 3005075853-2015-07020
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2D12LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2015
• 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): Hospitalization; Life Threatening