ECHELON*FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 45 MM

Report

Report Number: 3005075853-2014-03708
Event Type: Death
Date Received: June 2, 2014
Date of Event: May 6, 2014
Report Date: May 12, 2014
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K051002
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING WAS OBTAINED: AGAIN, SINCE PATIENT INFORMATION AND HEALTH RECORDS ARE CONFIDENTIAL IN ESTONIA THEN WE HAVE NO ACCESS TO THEM AND HOSPITALS ARE NOT ALLOWED TO SHARE THAT INFORMATION WITH THIRD PARTIES. THE LITTLE WE DO KNOW, I HAVE INCLUDED IN THE ANSWERS BELOW. HOW WAS THE INFECTION/SEPSIS OF THE SMALL BOWEL IDENTIFIED? DURING RE-OPERATION WHEN PATIENT WAS RE-ADMITTED TO THE HOSPITAL. WERE THERE ANY ISSUES NOTED OUTSIDE OF THE DEVICE LOCKOUT DURING INITIAL PROCEDURE? NO, ALL THE INFORMATION WE RECEIVED FROM THE CUSTOMER, WAS REPORTED IN THE COMPLAINT. AFTER THE LOCKOUT THEY USED THE SAME STAPLER FOR ANOTHER 2 FIRINGS WITHOUT ANY PROBLEMS. WHAT IS MEANT BY THE LARGE PART OF THE STOMACH? IS IT THE POUCH OR REMNANT PART OF THE STOMACH? REMNANT PART OF THE STOMACH. WAS THE STAPLER USED AT THE SITE OF THE BURST? THE STAPLER WAS USED TO CREATE THE SMALL POUCH, SO THERE WAS STAPLE LINE IN THE UPPER LEFT QUADRANT OF THE REMNANT STOMACH. THE BURST HOWEVER, HAPPENED BECAUSE THE REMNANT STOMACH OVERFILLED WITH DIGESTIVE JUICES, ETC. AND WAS NOT ABLE TO EMPTY ITSELF. WHAT WAS THE INDICATION FOR SURGERY? INITIAL SURGERY INDICATION WAS OBESITY, THE EXACT REASON FOR RE-OPERATION IS NOT KNOWN TO US. DID THE PATIENT HAVE ANY PRE-EXISTING CONDITION THAT WOULD HAVE IMPACTED THE OUTCOME TO THE PATIENT? NO INFORMATION ON PATIENT HISTORY. IS THE SURGEON WILLING TO SPEAK WITH AN EES MEDICAL DIRECTOR? NO. WAS THE PATIENT'S IMMUNE SYSTEM COMPROMISED PRIOR TO THE PROCEDURE? NO INFORMATION. WAS THE PATIENT TAKING STEROIDS? NO INFORMATION. WAS AN AUTOPSY PERFORMED? NO INFORMATION. DATE OF PATIENT DEATH? NO INFORMATION ON THE EXACT DATE OF DEATH.

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: THE EC45A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR45W CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: PREMATURE SLED MOVEMENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THERE A LEAK? DESCRIBE THE INFECTION IN THE SMALL BOWEL? WHERE THERE ANY ISSUES NOTED WITH STAPLER PERFORMANCE IN THE INITIAL PROCEDURE? WHAT IS MEANT BY SMOOTH AS IT SHOULD HAVE BEEN? WHAT WAS THE SITE OF LEAK OF THE REOPERATION? WHAT DID THE STAPLE FORMATION LOOK LIKE? HOW WAS THE LEAK DIAGNOSED? WAS THE PATIENT DISCHARGED AND RETURNED? IF SO, HOW DID THE PATIENT PRESENT? WHAT IS THE CURRENT STATUS OF THE PATIENT? THE EC45A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR45W CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS SURGERY, ECHELON FLEX 45MM WAS USED TO RESECT THE STOMACH AND CREATE GASTRO-ENTERO AND ENTERO-ENTERO ANASTOMOSIS. DURING THE 5TH FIRING, THE STAPLER WAS CLOSED ON SMALL BOWEL TO CREATE ENTERO-ENTERO ANASTOMOSIS, HOWEVER, THE DEVICE COULD NOT BE FIRED AS THE KNIFE WAS LOCKED OUT, SURGEON HAD TO OPEN THE DEVICE AND REMOVE IT FROM THE PATIENT, ANOTHER WHITE RELOAD WAS LOADED INTO THE STAPLER AND THE FIRING WAS COMPLETED WITHOUT ANY DIFFICULTIES. SURGEON MANAGED TO USE THE SAME STAPLER FOR ADDITIONAL 2 FIRINGS (ENTERO-ENTERO ANASTOMOSIS AND SMALL BOWEL RESECTION) AND BOTH TIMES IT WORKED AS INTENDED. ON (B)(6), THE PATIENT WAS RE-OPERATED DUE TO INFECTION IN THE SMALL BOWEL AND SEPSIS. SURGEON HAS INDICATED THAT THE STAPLER MAY OR MAY NOT HAVE PLAYED A ROLE IN THE INCIDENT AS THE FIRING AT THE FIRST ATTEMPT WAS NOT AS SMOOTH AS IT SHOULD HAVE BEEN DUE TO THE KNIFE THAT GOT STUCK. PROCEDURE WAS PROLONGED BY TEN MINUTES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
321114	ECHELON*FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 45 MM	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	ECR45W