FDA Adverse Event Malfunction Summary report: N

DST SERIES EEA XL 31 MM

MDR report key: 1081151 · Received July 15, 2008

Report

Report Number
1081151
Event Type
Malfunction
Date Received
July 15, 2008
Date of Event
June 30, 2008
Report Date
July 15, 2008
Manufacturer
COVIDIEN UNTIED STATES SURGICAL CORPORATION
Product Code
GDW
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PATIENT WITH RECTAL CANCER WITH HISTORY OF RECEIVING CHEMO-RADIATION, DATE UNKNOWN. IN FOR LOW ANTERIOR RESECTION OF RECTUM WITH TAKEDOWN OF SPLENIC FLEXURE AND DIVERTING LOOP ILEOSTOMY FOR PROTECTIVE PURPOSES. DURING SURGERY THE FOLLOWING EVENT OCCURRED, THE PROXIMAL COLON STAPLE LINE WAS EXCISED AND REPLACED WITH A HAND-SEWN PROLENE PURSESTRING, AND THEN THE EEA STAPLER SIZERS WERE USED. A 31 SIZE WAS CHOSEN AS THIS WAS ADMITTED EASILY INTO THE PROXIMAL BOWEL AND APPEARED TO BE ADEQUATE FOR THE DISTAL RECTUM AS WELL. THE ANVIL WAS SECURED WITH THE PURSESTRING WITHOUT INCIDENT AND SOME EXTRANEOUS FATTY TISSUE EXCISED WITH CAUTERY FROM THE ANASTOMOTIC SURFACE. THEN, THE EEA STAPLER WAS PLACED BY FIRST ASSISTANT PER RECTUM AFTER GOING BELOW TO DO THIS. THIS WAS DONE UNDER DIRECT VISION THROUGH THE PELVIC SIDE AS WELL, GUIDING THE INSTRUMENT EASILY TO THE STAPLE LINE OF THE RECTAL STUMP, KEEPING THE VAGINAL WALL CLEARLY OUT TO THE AREA. THE STAPLER WAS DEPLOYED. THE ANVIL ATTACHED TO POST. THE STAPLER WAS CLOSED. ON DOING THIS, THERE SEEMED TO BE ABNORMAL TIGHTNESS TO THE STAPLER. APPARENTLY, IT WAS DIFFICULT TO WIND DOWN AND THE GREEN INDICATOR DESPITE BEING COMPLETELY CLOSED DID NOT SHOW GREEN. THE COMPANY REP WAS IN THE ROOM AND THE RECOMMENDATIONS FOR THE DEVICE WERE QUITE STRICT REGARDING SHOWING GREEN IN THE INDICATOR BEFORE FIRING THE STAPLER. THE STAPLER WAS TIGHTENED FURTHER. AGAIN, IT SEEMED MORE DIFFICULT THAN AVERAGE TO REACH THIS POINT, AND FINALLY A SLIVER OF GREEN WAS VISIBLE ON THE INDICATOR. THE STAPLER WAS THEN FIRED AND THERE APPEARED TO BE A COMPLETE ANASTOMOSIS. WHEN CHECKING FOR LEAKS THERE APPEARED TO BE A BIG GAP POSTERIORLY IN THE STAPLE LINE. THE STAPLER FIRED ELSEWHERE INTACT ALL THE WAY AROUND. THERE WAS SOME DEGREE OF TENSION ON ANASTOMOSIS AS WELL DESPITE ASSESSING THIS BEFOREHAND, IT APPEARED ADEQUATE. SO, GIVEN STAPLER MALFUNCTION, THIS WAS SUBMITTED BACK TO THE COMPANY FOR EVALUATION. THE ANASTOMOSIS WAS TAKEN DOWN AND RE-DONE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DST SERIES EEA XL 31 MM STAPLER, SURGICAL GDW COVIDIEN UNTIED STATES SURGICAL CORPORATION * *

Patients

Seq Age Sex Outcome Treatment
1 62 YR