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

Catalog Number 00465

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Air Embolism (1697); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) ¿ blood pressure change; air/gas embolism occurred.Conclusion: actual device was returned for evaluation.Visual and functional inspections were performed.A damaged id board was found upon inspection and was repaired and replaced.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent trans-cervical resection procedure along with hysteroscopy procedure on an unknown date and electrosurgical device was used.During the procedure, the patient experienced an air and gas embolism and drop in blood pressure.As result of this event, the surgeon stopped the procedure.Additional information has been requested.

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5140156
• MDR Text Key: 27917277
• Report Number: 2210968-2015-14803
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• 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
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00465
• Device Lot Number: GY1120588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention