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); Surgical procedure, additional (2564)

Event Date 05/13/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent an electrosurgical procedure on (b)(6) 2014.During the procedure, the loop of the resector electrode first bent and subsequently broke off.An additional intervention to retrieve the lost piece was interrupted.Currently, a 3/4mm piece remains in the patient and has not been removed.The surgeons are having a clinic evaluation to remove it.No additional information was provided.

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.

• 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 015
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road, st. mellons; cardiff CF3 OLT; UK CF3 OLT
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3843241
• MDR Text Key: 4410972
• Report Number: 2210968-2014-06926
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention