KOH COLPOTOMIZER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-24 for KOH COLPOTOMIZER * manufactured by Cooper Surgical.

Event Text Entries

[19176509] The patient had mild postmenopausal vaginal bleeding and well-differentiated endometrial adenocarcinoma, and underwent a robotic-assisted total laparoscopic hysterectomy/bilaterial salpingo-oophorectomy and bilaterial pelvic lymph node dissection. A rumi uterine manipulator with a 6 cm tip and a small koh ring were inserted into the uterus via the cervix for uterine manipulation. A vaginal occluder balloon was placed around the uterine manipulator to continue pneumoperitoneum after entry to the vagina during hysterectomy. The abdomen was filled with approximately 3 liters of carbon dioxide, after which the laparoscope was inserted to confirm intraperitoneal positioning of the sleeve. The robot was docked to the laparoscopic ports and the ligaments were cauterized and cut bilaterally. A circumferential incision was made around the upper vagina, around the koh ring, and was inserted thereby separating the cervix from the vagina and uterosacral ligaments. The specimen was removed through the vagina. Pneumo pressure was lost and the leak was sealed vaginally. Re-inflation of the abdomen was completed and the vaginal cuff was closed. At this point in the procedure, visualization of the koh ring was lost, which meant the device could have migrated from the pelvic area. Attention was then turned to the pelvic lymph node dissection, and the specimen was removed and placed in a bag. The abdomen and pelvis were irrigated with warm saline, and hemostasis was excellent. All of the laparoscopic instruments and trocars were removed. At the end of the procedure, all needles, sponge, and instrument counts were noted as correct. The patient was referred for radiation therapy, and a ct scan of the abdomen was performed. Review of the scan revealed a retained foreign body from the surgery (the koh ring). One month later, laparoscopy procedure was preformed to remove the retained foreign body. The koh ring was grasped and successfully removed through the right lower quadrant incision.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1104063
• MDR Report Key: 1104063
• Date Received: 2008-07-24
• Date of Report: 2008-07-24
• Date of Event: 2008-06-06
• Report Date: 2008-07-24
• Date Reported to FDA: 2008-07-24
• Date Added to Maude: 2008-08-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KOH COLPOTOMIZER
• Generic Name: ACCESSORY, COLPOTOMY
• Product Code: HDM
• Date Received: 2008-07-24
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL
• Manufacturer Address: 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2008-07-24