MAUDE Adverse Event Report: LSI SOLUTIONS LSI SOLUTIONS; FORNISEE 30 MM CUFF

Model Number 110030, 110105

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 03/18/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 a (b)(6) female, asa 2, bmi (b)(6) underwent a routine total laparoscopic hysterectomy due to severe dysmenorrhagia.During the procedure it was noted omental adhesions to the anterior abdominal wall and uterus scar noted from the forniecs uterine manipulator which further perforated a venous vessel.The procedure was immediately converted to laparotomy to open the abdomen and a general surgeon was consulted.At this point, good hemostasis was achieved and it was discussed/decided to proceed with the hysterectomy.Upon the closure of the vaginal cuff, the appearance of venous blood was noted from the previous vessel dissection site and pressure was again applied and general surgeons were consulted.With two general surgeons present, they noted bleeding developing in the left iliac region.Ligation occurred to the proximal and distal common internal iliac vein and proximal common external vein.The patient was treated with resuscitative blood products, due to an estimated blood loss of 3l, while the surgeons controlled the bleed and patient was prepared for transfer.The patient was transferred via ems with abdomen open and physician maintains manual pressure to control the bleed to cath lab at (b)(6) medical center for venogram and admission to icu.

• Brand Name: LSI SOLUTIONS
• Type of Device: FORNISEE 30 MM CUFF
• Manufacturer (Section D): LSI SOLUTIONS; 7796 victor-mendon rd.; victor NY 14564
• MDR Report Key: 3821239
• MDR Text Key: 4397623
• Report Number: MW5036160
• Device Sequence Number: 1
• Product Code: HEW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 110030, 110105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 34 YR
• Patient Weight: 79