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

Catalog Number 01942

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a hysteroscopy and myomectomy on (b)(6) 2014 and an electrosurgical device was used to cut and resect an intrauterine myoma.During the procedure, the loop broke from one side of it's connection to the electrode body.Another like device was used to complete the procedure with no adverse patient consequences.

Manufacturer Narrative

(b)(4).Conclusion: 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.Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch ugy1404050, batch ugy1403160.

Manufacturer Narrative

It was reported that one side of the electrode loop wire broke from the electrode.The loop wire stayed attached to the electrode body on the other side so it didn¿t fall into the patient.Additional information: - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch ugy1404050, mfg date: 04/2014, exp date: unk.Batch ugy1403160, mfg date: 04/2014, exp date: unk.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.

Manufacturer Narrative

Conclusion: the actual device involved in this event was returned for evaluation.The device was visually and functionally evaluated.Upon evaluation, there was damage to the active tip of the device.One side of the active tip had became detached from the active side of the electrode.Closer inspection of the failed active tip suggests a ductile failure mode.The likely cause of the failure is excessive force exerted on to the tip during use, and/or as a result of the tip angle being changed numerous times causing the failure.

• 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: 4357467
• MDR Text Key: 5119275
• Report Number: 2210968-2014-17011
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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,Followup,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2015; 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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