ENDOPATH THORACIC ENDOLINEAR CUTTER W/SAFETY LOCKOUT

MDR report key: 85322 · Received January 30, 1997

Report

Report Number: 1527736-1997-00058
Event Type: Malfunction
Date Received: January 30, 1997
Date of Event: January 2, 1997
Report Date: January 29, 1997
Manufacturer: ETHICON ENDO-SURGERY, INC.
Product Code: GAG
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ID, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

BROKEN FIRING TRIGGER TEETH AND BROKEN SHORT RACK TEETH.

Description of Event or Problem · 1

DURING A LUNG RESECTION THE EZ45B, SERIAL NUMBER 0280, FIRED WITHOUT DIFFICULTY ON THE FIRST FIRING. AFTER IT WAS RELOADED, NO STAPLES WERE FORMED. ANOTHER EZ45B WAS OPENED, SERIAL NUMBER 0278, AND ALSO LOCKED OUT. THE CASE WAS FINISHED WITH A COMPETITIVE PRODUCT. THERE WAS NO CONSEQUENCE TO THE PATIENT. CLINICAL FOLLOW UP: 1/6/97 1350 MESSAGE AND 800 NUMBER LEFT FOR SURGEON TO CALL BACK. 1/7/97 1445 SURGEON CALLED BACK STATING HE DID NOT PERFORM THIS PROCEDURE, BUT BELIEVED A DR MAY BE THE SURGEON WHO EXPERIENCED THE DIFFICULTY. 1/7/97 1455 PAGED SALES REP WHO CALLED BACK AND ASKED HIM TO FOLLOW UP WITH THIS SURGEON REGARDING THIS INQUIRY. THE SALES REP SAID HE WOULD CALL BACK. 1/10/97 1000 REP CALLED BACK WITH SURGEON INFORMATION. 1/10/97 MESSAGE AND 800# LEFT FOR MD CALL BACK. 1/10/97 FROM THE SURGEON'S OFFICE RETURNED CALL AND STATED THE SURGEON WILL NOT BE IN THE OFFICE UNTIL THE END OF NEXT WEEK. NNCL SENT 1/22/97 SURGEON CALLED BACK AND STATED THE TWO EZ45S WOULD NOT FIRE ON FIRST FIRING. THEY WERE RELOADED BUT WOULD NOT FIRE. THE INSTRUMENTS CLOSED OK ON TISSUE, AND THE FIRING LEVER MOVED THROUGH THE FIRING MOTION, BUT NOTHING HAPPENED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH THORACIC ENDOLINEAR CUTTER W/SAFETY LOCKOUT	ENDOSCOPIC LINEAR CUTTER	GAG	ETHICON ENDO-SURGERY, INC.	NA	J4249K

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other