FDA Adverse Event Malfunction Summary report: N

75MM SELECTABLE NEW TLC

MDR report key: 1850423 · Received September 20, 2010

Report

Report Number: 3005075853-2010-05362
Event Type: Malfunction
Date Received: September 20, 2010
Date of Event: August 26, 2010
Report Date: August 26, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC
Product Code: GDW
PMA / PMN Number: K092577
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DATE SENT: 09/20/2010.: INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. EVALUATION SUMMARY. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A COLECTOMY J-POUCH PROCEDURE, THE DEVICE WAS FIRED WITH EIGHT RELOADS. THE 6TH FIRING WAS THE FIRST FIRING OF THE POUCH. THE 7TH FIRING WAS DIFFICULT TO FIRE AND 3/4 OF THE WAY INTO THE FIRING, THE DEVICE CAME TO A STOP. THE SURGEON REMOVED THE DEVICE AND RELOADED IT TO COMPLETE THE ANASTOMOSIS. IT WAS DIFFICULT TO FIRE THE 8TH FIRING THEN THE FIRING KNOB BROKE OFF OF THE DEVICE. NO PIECES FELL INTO THE PT. THE SURGEON USED SCISSORS AND A TLC DEVICE WITH A BLUE LOAD TO COMPLETE THE CASE. NO ADVERSE CONSEQUENCES REPORTED. THERE WAS NO TISSUE DAMAGE. THE DEVICE AND RELOADS WERE DISCARDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	75MM SELECTABLE NEW TLC	GDW STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC	NA	G4RZ0R

Patients

Seq	Age	Sex	Outcome	Treatment
1				RELOAD SR75, LOT # G4RZ46