ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

Report

Report Number: 3005075853-2010-06304
Event Type: Death
Date Received: November 4, 2010
Date of Event: October 15, 2010
Report Date: October 19, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: KOG
PMA / PMN Number: K940967
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: DUE TO HIGH PRESSURE OF VERY LARGE AMOUNT OF FECES IT COULD BE POSSIBLE THAT ANASTOMOSIS WAS BLOWN OUT ON VENTRAL SITE; THE SURGEON ON THE SECOND OPERATION NOTICED THAT SOME STAPLES WERE NOT COMPLETELY FORMED (THEY WERE BENT OUTWARDS). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010: DID THEY PERFORM THE LEAKAGE TEST AFTER FINISHING THE ANASTOMOSIS, WAS THE LEAKAGE TEST OK' THEY DID A LEAKAGE TEST WITH IODINE WATER SOLUTION: NO LEAKAGE. THERE WERE NO TECHNICAL PROBLEMS WITH THE DEVICE DURING THE OPERATION, ANASTOMOSIS WAS LYING WITHOUT AND TENSION WAS WELL VASCULARIZED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

Additional Manufacturer Narrative · 1

(B)(4): ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING RESPONSE WAS RECEIVED: WAS THE PROCEDURE DONE OPEN/LAPAROSCOPICALLY? THEY STARTED LAPAROSCOPICALLY, BUT DUE TO THE FACT THAT THE PATIENT COULDN'T BE VENTILATED WHEN PLACED IN TRENDELENBURG THEY DECIDED TO CONVERT TO OPEN . WHAT DEVICE WAS USED FOR THE PROXIMAL AND DISTAL TRANSACTION OF THE BOWEL? PROXIMAL: TLC75, DISTAL TL60. WHAT COLOR RELOAD? TLC75 ( = BLUE ), TL60: VARIABLE STAPLE HEIGHT. ON WHAT TISSUE TYPE WAS THE DEVICE USED? SIGMOID. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE IN HIS/HER LEFT COLON PROCEDURES? (EX. HAND TIED PURSE STRING, PURSE STRING DEVICE) MANUALLY= HAND TIED PURSE STRING. HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE, WHAT PRODUCT? BY HAND. WAS THE SPIKE OF THE TROCAR INSERTED THROUGH BOWEL LATERAL OR THROUGH THE STAPLE LINE? THROUGH THE STAPLELINE. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? A NORMAL CLICK WAS AUDIBLE. WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE? HALFWAY. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES, ACROSS STAPLELINE. THIS IS UNAVOIDABLE WHEN INSERTING SPIKE THROUGH DISTAL STAPLELINE HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? AUDIBLE CRUNCH WAS HEARD AFTER USE, DID THE FIRING HANDLE AUTOMATICALLY RETURN TO ITS ORIGINAL (PRE-FIRED) POSITION WITHOUT INTERVENTION? YES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE, PROCEDURE, PATIENT OR PHYSICIAN? ANASTOMOSIS WAS TESTED WITH IODINE SOLUTION : THERE WAS NO LEAKAGE AND DONUTS WERE COMPLETE. NO TENSION ON ANASTOMOSIS. PULMONARY CONDITION PRIOR TO SURGERY WAS ALREADY NOT SO GOOD. PATIENT USED MEDICATION FOR THIS CONDITION. DID A HCP OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? OBSTRUCTING TUMOR IN SIGMOID, SEMI - URGENT. CAN YOU PLEASE PROVIDE MORE INFORMATION ON THE PATIENT'S HISTORY OF "BAD PULMONARY CONDITION?. PULMONARY CONDITION PRIOR TO SURGERY WAS ALREADY NOT SO GOOD. PATIENT USED MEDICATION FOR THIS CONDITION. AFTER SURGERY, PATIENT DEVELOPED CANDIDA BACILLI IN THE LUNGS WHICH GAVE MORE PROBLEMS THAN STOMA ( WHICH WAS CONSTRUCTED AFTER SECOND SURGERY ). STOMA FUNCTIONED WELL. WAS THE PATIENT'S CONDITION CRITICAL DUE TO THE MALFORMED STAPLES OR DUE TO THE PATIENT PULMONARY CONDITION? MAINLY DUE TO PULMONARY CONDITION. WHAT IS THE CURRENT CONDITION OF THE PATIENT? IS THE PATIENT STILL ON LIFE SUPPORT? STILL IN THE ICU? STILL IN THE HOSPITAL? PATIENT DECEASED END OF NOVEMBER. WHAT WAS THE PATIENT'S CAUSE OF DEATH? ABSTINENCE : A FISTULA LOCATED IN TRACHO OESOPHAGUS DUCT CAUSED BY AN CANDIDA INFECTION WAS CAUSE OF DEATH WHAT WAS THE DATE OF THE PATIENT'S DEATH? (B)(6) 2010.

Description of Event or Problem · 1

IT WAS REPORTED THAT AFTER A LOW ANTERIOR RESECTION PROCEDURE, BECAUSE OF AN OBSTRUCTIVE TUMOR IN THE SIGMOID, A SIDE "TO-END ANASTOMOSIS WAS CREATED WITH NO PROBLEMS. THERE WERE COMPLETE DONUTS, TENSION-FREE ANASTOMOSIS, AND NO TEMPORARY COLOSTOMY WAS CREATED. ONE DAY AFTER THE INITIAL SURGERY, THE CONDITION OF THE PATIENT WAS WORSENING AND THE PATIENT HAD TO BE RE-OPERATED BY THE RESIDENT DUE TO PERITONITIS: 4 LITERS OF LIQUID-FECES WAS REMOVED FROM THE PATIENT'S ABDOMEN. AFTER LOOKING CAREFULLY AT THE ANASTOMOSIS SITE, IT WAS CLEAR THAT ON THE VENTRAL SITE THERE WERE SOME SMALL OPENINGS WHERE THE STAPLES WERE BENT OUTWARDS. THE PATIENT'S CONDITION PRE-OPERATIVE (INITIALLY) WAS NOT GOOD; PULMONARY CONDITION WAS VERY BAD. DEVICE WITH PACKAGE WAS THROWN AWAY, BECAUSE THE INITIAL PROCEDURE WAS PERFORMED WITHOUT ANY PROBLEM. THE CONDITION OF THE PATIENT IMMEDIATELY FOLLOWING THE EVENT WAS CRITICAL AND THE PATIENT IS IN ICU AT THIS MOMENT ((B)(6)) ON LIFE SUPPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM	CIRCULAR STAPLERS	KOG	ETHICON ENDO-SURGERY, LLC.		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Death\| O\| R