THE KOH COLPOTOMIZER SYSTEM (KOH CUP VAGINAL FORNICES DELINE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-10 for THE KOH COLPOTOMIZER SYSTEM (KOH CUP VAGINAL FORNICES DELINE * manufactured by Cooper Surgical.

Event Text Entries

[16701643] Recently a 72 year old female underwent a laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and lysis of adhesions using an uterine manipulator injector system. Physicians had been trained in the use of the other system and were now trialing the koh colpotmizer system with two company representatives present in the or. The procedure was uncomplicated and the patient was transferred to the recovery room in stable condition. The patient was discharged the day following surgery. Approximately 14 days later, she was seen by the attending surgeon for post-operative follow-up with no complaints. Approximately 3 weeks following, during a recheck with the attending surgeon, a vaginal exam was completed revealing a blue colored object present in the top of the vaginal vault. An unsuccessful attempt was made to remove the foreign body in the office. The patient was taken to surgery and given a spinal anesthesia with easy removal of the retained collar, a blue resin cup from the koh colpotomizer system. Vaginal exam appeared to be normal with minimal bleeding. The patient was discharged in stable condition when alert and awake. The patient is recovering without any residual side effects.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1214248
• MDR Report Key: 1214248
• Date Received: 2008-10-10
• Date of Report: 2008-10-10
• Date of Event: 2008-07-30
• Report Date: 2008-10-10
• Date Reported to FDA: 2008-10-10
• Date Added to Maude: 2008-10-30
• 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: THE KOH COLPOTOMIZER SYSTEM (KOH CUP VAGINAL FORNICES DELINE
• Generic Name: ACCESSORY, COLPOTOMY
• Product Code: HEX
• Date Received: 2008-10-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 1260619
• Manufacturer: COOPER SURGICAL
• Manufacturer Address: 95 CORPORATE DRIVE TRUMBULL CT 06611 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-10-10