ENSEAL G2 STRAIGHT JAW

Report

Report Number: 3005075853-2014-04139
Event Type: Malfunction
Date Received: June 19, 2014
Date of Event: October 3, 2013
Report Date: November 22, 2013
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GEI
PMA / PMN Number: K112033
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RECEIVED WITH THE TOP OF THE I-BLADE FRACTURED AND LIFTED, THE JAW WAS DETACHED RETURNED. IN ADDITION, THE ENERGY BUTTON WAS DETACHED AND RETURNED WITH THE INSTRUMENT. IT IS LIKELY THAT THE BUTTON WAS DISLODGED DURING TRANSIT. THE BUTTON WAS REATTACHED TO THE INSTRUMENT AND CONNECTED TO THE GENERATOR AND IT WAS RECOGNIZED. BECAUSE THE I BLADE WAS DAMAGED NOT ALL TESTING WAS PERFORMED WITH THE GENERATOR. THE CONDITION OF THE BLADE PREVENTED THE FUNCTIONALITY OF THE JAW. THE JAW WAS UNABLE TO CYCLE OPEN AND CLOSE. THERE IS INSUFFICIENT EVIDENCE RELATED TO WHAT CAUSED THE DAMAGE; A PROBABLE CAUSE OF THE DAMAGE TO THE I BLADE COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE BUTTON DETACHED FROM THE INSTRUMENT IT SHOULD BE NOTED THAT OUR MANUFACTURING PROCESS VERIFIES THE PRESENCE AND FUNCTIONALITY OF THE INSTRUMENT PRIOR TO SHIPPING.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE GET BROKEN JAW, NO PART FELLED IN THE PATIENT. ANOTHER DEVICE LIKE DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
360101	ENSEAL G2 STRAIGHT JAW	ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES	GEI	ETHICON ENDO-SURGERY, LLC.	NA	K4CH8K

Patients

Seq	Age	Sex	Outcome	Treatment
1				GENERATOR AND HANDPIECE