FDA Adverse Event Malfunction Summary report: N

NSEAL

MDR report key: 1983519 · Received February 10, 2011

Report

Report Number: 3005075853-2011-00544
Event Type: Malfunction
Date Received: February 10, 2011
Date of Event: February 1, 2011
Report Date: February 2, 2011
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GEI
PMA / PMN Number: K072177
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. NO JAW DAMAGED WAS NOTED. THERE WAS NO TISSUE EXTRUDED THROUGH THE I-BLADE, NOR ANY TISSUE STUCK IN THE APEX OF THE JAW. THE JAWS WERE NOT BENT NOR WAS THE I-BLADE DISTORTED. DURING FUNCTIONAL TESTING, THE I-BLADE ADVANCED AND THE JAW OPENED AND CLOSED AS INTENDED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE.

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, WHEN THE DEVICE WAS ACTIVATED ON THE LIGAMENTUM TERES, THE JAW BECAME NOT TO OPEN. THE SALES REP WHO ATTENDED THE OPERATION SUGGESTED RETURNING THE HANDLE TO THE HOME POSITION, BUT THE DOCTOR WAS NOT ABLE TO RETURN THE HANDLE TO THE HOME POSITION BECAUSE IT WAS TOO HARD. FINALLY, THE AMBILATERAL TISSUE OF THE JAW WAS CLAMPED BY FORCEPS AND CUT BY SCISSORS TO REMOVE THE DEVICE (TISSUE HAD BEEN SEALED PRIOR). ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. WHEN THE SALES REP TRIED TO OPEN THE HANDLE AFTER RELEASING THE JAW, THE HANDLE WAS OPENED SMOOTHLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NSEAL	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	GEI	ETHICON ENDO-SURGERY, LLC.	UNK	G4TV28

Patients

Seq	Age	Sex	Outcome	Treatment
1				GENERATOR