MAUDE Adverse Event Report: FORNISEE SYSTEM UTERINE MANIPULATOR; CULDOSCOPE AND ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

(b)(4).

Manufacturer Narrative

On (b)(4) 2014, we were informed that a uterine perforation occurred during a total laparoscopic hysterectomy involving the fornisee system uterine manipulation product.The surgeon had experience with the fornisee technology with three prior robotic hysterectomies.In those initial cases, the physician assistant at the operating room tableside manually controlled this hand-operated device, while the surgeon performed the dissection away from the pt at the robotic console.This event involved the surgeon's first laparoscopic, non-robotic, surgery with this product; here the surgeon himself held and controlled the fs device with one hand and performed the dissection with the other.We were told that this pt has survived but experienced significant bleeding and required intervention.The fornisee product includes a metal reusable sound, called the fs sound, the distal end of which is passed preoperatively through the cervical os, cervical canal and into the uterine fundus.The fs sound has a distal end that is rotated 90 degrees after insertion into the uterine cavity.The plastic handle, called the fs device, is slid over the fs sound and through the pt's vaginal canal.The fs device has a cervical cup feature to engage the cervix and provide illumination at the area of colpotomy dissection.Reportedly, after initiating laparoscopy, some anterior wall and omental adhesions were taken down.Some dissection may have occurred near the left round ligament but none at the right round ligament.No broad ligament or tubo-ovarian ligament dissection for uterine mobilization was observed on either side.The surgeon completed the bladder flap dissection.Subsequently, the fs device's distal fully rotated end was observed outside of the uterine body.According to their medwatch report, bleeding was noted and attributed to an unobserved assessment that this uterine perforation event also "perforated a venous structure." immediate conversion to laparotomy occurred.A general surgeon was brought in.They reported, "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." while we have had limited communication with this hosp, we were told that the pt had continued to improve.The hosp has not released the fs sound for our eval.Based on our understanding of this event, we do not believe this represents a device malfunction.(b)(4).We believe this unfortunate event is not due to a technology design or mfg problem, but rather a known risk related to the use of uterine sounds and manipulators in gynecologic surgery.Fortunately, the pt appears to be healing well.

• Brand Name: FORNISEE SYSTEM UTERINE MANIPULATOR
• Type of Device: CULDOSCOPE AND ACCESSORIES
• Manufacturer Contact: kevin bentley ; 7796 victor-mendon rd.; victor, NY 14564 ; 5858696669
• MDR Report Key: 3807873
• MDR Text Key: 4387944
• Report Number: 1320468-2014-00012
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• PMA/PMN Number: K111014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Type of Report: Initial

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?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1