MAUDE Adverse Event Report: ETHICON INC. GYNECARE VERSAPOINT II BIPOLAR ELECTROSURGERY SYSTEM; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR

Catalog Number 01942

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Blood Loss (2597); No Code Available (3191)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown polypectomy procedure on (b)(6) 2016 and the electrosurgical device was used to remove a polyp from the patient.During use, there were no device issue.However, at the post procedure, when the doctor performed a dilation and curettage to remove the tissue chips, the patient went into distress.The doctor opined that he must have perforated the uterus and knicked an artery.A laparotomy was performed to stop the bleeding and repair the damage.It was also reported that it was hard to state when the doctor perforated the uterus with the instrumentation during initial procedure or with the curette after the polypectomy.No further information is available.

Manufacturer Narrative

Date sent to fda: 01/18/2017.Additional information was requested and the following was received: the patient demographic info: age, weight and bmi at the time of index procedure no information.Date of initial surgical procedure (b)(6) 2016.The diagnosis and indication for the initial surgical procedure? polyps - polypectomy.What were current symptoms following the index surgical procedure? onset date? unknown.Other relevant patient history/concomitant medications no information.Product code and serial number? (b)(4).Will the generator be returned for evaluation? no.What is physician¿s opinion as to the etiology of or contributing factors to this event? no information.Does the surgeon believe there was a defect with the versapoint generator that caused the uterine perforation? no.Any pictures available? no.What is the patient¿s current status? unknown.

• Brand Name: GYNECARE VERSAPOINT II BIPOLAR ELECTROSURGERY SYSTEM
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road, st. mellons; cardiff CF3 O LT; UK CF3 OLT
• Manufacturer Contact: darlene kyle ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6225081
• MDR Text Key: 63950454
• Report Number: 2210968-2017-30076
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K111751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01942
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention