MAUDE Adverse Event Report: ETHICON DILATING TIP TROCAR

Device Problem Insufficient Information (3190)

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

Event Date 03/27/2015

Event Type  Injury  

Event Description

Elective robotic assisted hysterectomy was converted to exploratory laparotomy for vascular repair and subsequent abdominal hysterectomy.Following insufflation to 20 mmhg, a sharp 12 mm 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.

• Brand Name: DILATING TIP TROCAR
• Type of Device: DILATING TIP TROCAR
• Manufacturer (Section D): ETHICON; guayanabo PR 00969
• MDR Report Key: 4925235
• MDR Text Key: 6008662
• Report Number: MW5044440
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 52 YR
• Patient Weight: 41