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

Catalog Number 01942

Device Problem Break (1069)

Patient Problems Nonresorbable materials, unretrieved in body (2276); Device Embedded In Tissue or Plaque (3165)

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent a hysteroscopy procedure on (b)(6) 2015 and an electrosurgical device was used.During the procedure, the electrode tip broke into the patient.Additional information was requested.

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Manufacturer Narrative

In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Conclusion: the actual device was returned for evaluation.Visual examination was revealed that the active tip of the device shows signs of activation and the active loop missing.There are signs of possible incorrect fitment of the electrode to the resectoscope as seen from the scuffing on the arms and also signs of possible physical manipulation of the arms as seen by the position of the arms.(b)(4).

• 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: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4799803
• MDR Text Key: 5880145
• Report Number: 2210968-2015-06464
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K111751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01942
• Device Lot Number: UGY1410085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/29/2015; 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other