ENSEAL G2 STRAIGHT JAW
Report
- Report Number
- 3005075853-2016-01433
- Event Type
- Death
- Date Received
- March 14, 2016
- Date of Event
- February 11, 2016
- Report Date
- February 18, 2016
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GEI
- PMA / PMN Number
- K112033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
(B)(4). THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.
(B)(4). ADDITIONAL INFORMATION: BATCH # M92072 . THE DEVICE WAS RETURNED INSIDE OF THE PRIMARY PACKAGE AND THE STERILE PACKAGE IN GOOD PHYSICAL CONDITION. THE STERILE PACKAGE WAS OPEN TO ANALYZE THE DEVICE. THE DEVICE WAS TESTED ON THE GENERATOR AND PASSED ALL FUNCTIONAL TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED. ALL THREE TONES WERE HEARD DURING FUNCTIONAL TESTING (TONE 1 IS HEARD WHEN THE ENERGY ACTIVATION BUTTON IS PRESSED; TONE 2 IS HEARD WHEN TISSUE IMPEDANCE THRESHOLD IS REACHED AND TONE 3 IS HEARD WHEN THE CYCLE IS COMPLETE). THE DEVICE WAS TESTED WITH THE TEST MEDIA AND NO ANOMALIES WERE FOUND. NO ALERT SCREENS WERE DISPLAYED DURING TESTING. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN IS DISPLAYED AFTER RECEIVING TWO CONSECUTIVE ALERT SCREENS AND IS ADVISING OF A POTENTIAL ISSUE WITH THE INSTRUMENT. HOWEVER; NO ALERT SCREENS WERE DISPLAYED DURING TESTING.
(B)(4). ADDITIONAL INFORMATION ASKED AND OBTAINED: NON- IDENTIFYING PATIENT INFORMATION - AGE, WEIGHT, HEIGHT AND PRE-EXISTING MEDICAL CONDITIONS? PATIENT IS FEMALE BETWEEN 50-60 - BMI IS AVERAGE. PLEASE QUANTIFY THE AMOUNT OF BLOOD THE PATIENT LOST DURING THE PROCEDURE. LOSS OF BLOOD WAS 1000 ML DID THE PATIENT REQUIRE A TRANSFUSION DURING THE PROCEDURE: IF SO, HOW MUCH BLOOD WAS TRANSFUSED. NO TRANSFUSION WAS GIVEN. WHAT WAS THE REASON FOR THE PANCREATECTOMY; WHAT WAS THE PREOPERATIVE DIAGNOSIS: THE PRE-OPERATIVE DIAGNOSIS WAS A 4CM CYST, WHICH ONCE RUPTURED, LOW VOLUME. REGARDING THE POSTPANCREATECTOMY HEMORRHAGE, HOW MANY HOURS POST-OP WAS THE DECISION TO RE-OPERATE MADE AND WERE THERE ANY OTHER INDICATIONS OF BLEEDING PRIOR TO THE DEVELOPMENT OF SHOCK? NO HYPOTENSION OR SHOCK DURING THE PROCEDURE WHERE WAS THE SECOND ENSEAL DEVICE USED (WHAT STRUCTURES): IT WAS MAINLY USED FOR DISSECTION AND EXPOSURE ON LITTLE VASCULARIZED STRUCTURES. DOES THE SURGEON/ACCOUNT UNDERSTAND THE ALERT SCREENS AND WHAT TROUBLESHOOTING STEPS ARE REQUIRED: THE SURGEON IS AN EXPERIENCED USER OF ENSEAL, HAS BEEN USING FOR OVER A YEAR IN A UNIVERSITY/HOSPITAL SETTING. AS WELL HE WENT TO CINCINNATI FOR TRAINING. THIS IS BEING ASKED BECAUSE THE EVENT STATES: DEVICE #1 - HAD MULTIPLE ERROR CODES, SUCH AS REPLACE INSTRUMENT, ETC. THEY UNPLUGGED AND RE-PLUGGED IN THE DEVICE. THE GENERATOR ADVISED THAT THE DEVICE NEED TO BE REPLACED, NOT TO UNPLUG AND RE-PLUG BACK INTO THE GENERATOR. WHY WAS THE DEVICE NOT REPLACED AT THAT TIME: THERE WERE A NUMBER OF ERROR CODES GIVEN BY THE GEN11. AT LEASE 3X, THE ENSEAL SHEAR HAD TO BE DISCONNECTED AND RECONNECTED. EACH TIME AFTER FOLLOWING RECONNECTION THE TONES WERE HEARD AND AN EFFECT ON THE TISSUE COULD BE SEEN. WHEN APPLICATION OF THE ENSEAL WAS DONE ON THE SPLENIC VEIN, OR A BRANCH OF THE VEIN OCCURRED. THE SURGICAL PLANE SEEMED AVASCULAR. ON REMOVING THE DEVICE, THERE WAS BLEEDING. THEY WANTED TO CONTROL THE BLEEDING WITH THE ENSEAL; THE DEVICE COMPLETELY STOPPED WORKING (NO TONES HEARD, NO EFFECT ON TISSUE). A NEW DEVICE WAS OPENED AND USE, AND IT WORKED NORMALLY (TONES HEARD AND THERE WAS AN EFFECT ON TISSUES). THE BLEEDING COULD NOT BE CONTROLLED WITH THE ENSEAL, THEY HAD TO USE CLIPS AND THEN ULTIMATELY STAPLER - NEITHER OF THESE WERE J&J DEVICES. THE BLEEDING WAS CONTROLLED WITH STAPLES. THE 2ND SHEAR WAS USED FROM THE REMAINDER OF THE PROCEDURE, AND BEHAVED NORMALLY. ALL INSTRUMENTS WERE DISCARDED AFTERWARDS. WAS THE PATIENT GIVEN ANY PRE-OP ANTICOAGULANTS OR HAD THEY BEEN ON CHRONIC ANTICOAGULANT THERAPY PRIOR TO THE SURGERY; IF SO, WHICH: SHE WAS TAKING NO ANTICOAGULANT STYLE MEDICATION OTHER THAN HEPARIN SUBCUTANEOUSLY, AS IS STANDARD PRE-OP PROTOCOL. POST OP - PATIENT WAS TAKEN TO INTENSIVE CARE FOR MONITORING BECAUSE OF THE BLEEDING DURING THE SURGERY. THE HEMOSTASIS LOOKED PERFECT AT THE END OF THE SURGERY. THURSDAY - THERE WAS NOTHING UNUSUAL WAS MONITORED. FRIDAY - DRAIN EXSUDANT WAS ACCEPTABLE FOR THIS TYPE OF SURGERY A HEMOBLOGIN CONTROL TEST WAS DONE ONCE AND WAS IN THE NORMAL LIMITS FOR THIS TYPE OF SURGERY. SATURDAY - MORE SIGNIFICANT DRAINAGE. A HEMOGLOBIN CONTROL TEST WAS DONE AT 6H PERIODS, WITHIN ACCEPTABLE LIMITS EACH TIME 3AM PATIENT CALLED FOR ASSISTANCE, ALMOST IMMEDIATELY FELL INTO SHOCK, REQUIRE EMERGENCY REOPERATION. LAPARATOMY SPLENECTOMY. MASSIVE HEMOPERITONEUM, AT LEAST 3L OF BLOOD WAS RECOVERED. SOURCE OF BLEEDING NOT OBJECTIFIED AT THIS POINT. SPLEEN WAS NORMAL, NO VISIBLE SIGNS OF HEMATOMOA
(B)(4). ADDITIONAL INFORMATION RECEIVED: THE SALES REP. WAS AWARE THAT THE ACCOUNT UNPLUGGED AND RE-PLUGGED THE DEVICE INTO THE GENERATOR MULTIPLE TIMES DURING THE PROCEDURE AND ADVISED THAT IS NOT WHAT SHE HAS INSTRUCTED THE ACCOUNT DO IF THEY ENCOUNTER ERROR CODES. SHE INDICATED THAT THERE ARE VERY SPECIFIC INSTRUCTIONS ON HOW TO HANDLE THE ERROR CODES AND THAT, IN THIS CASE, THE DEVICE SHOULD HAVE BEEN REPLACED. SHE WILL BE REINFORCING THIS POINT WITH THE ACCOUNT DURING AN IN-SERVICE OPPORTUNITY. INFORMATION OBTAINED FROM SURGEON: I WAS DOING A PANCREATECTOMY ON A LADY THAT HAD CYST. DURING DISSECTION, THE DEVICE DID NOT WORK; ACTIVATION HAD NO SOUND. NURSE INSTRUCTED TO UNPLUG AND RE-PLUG. THIS HAPPENED TWO TIMES WITH NO CONSEQUENCE; NO BLEEDING. AT THE SPLENIC HILUM TOWARD THE END OF THE SPLENIC VEIN THERE WAS BLEEDING. I TRIED TO COAGULATE, DID NOT WORK. APPLIED PRESSURE AND CHANGED THE DEVICE. TESTED THE DEVICE AND TRIED TO COAGULATE AND SEEMED TO WORK BUT COULD NOT CONTROL THE BLEEDING. EVENTUALLY THE BLEEDING WAS CONTROLLED AND CHECKED FOR HEMOSTASIS. THERE WAS NO SIGN OF ACTIVE BLEEDING. TISSEEL APPLIED TO THE PANCREAS. THE PATIENT RECEIVED A DRAIN. CHECKED THE PATIENT THIRTY MINUTES AFTER AND IT WAS FINE AND PATIENT WAS SENT TO THE INTENSIVE CARE UNIT AS USUAL AND MONITORED. ON POST-OP DAY TWO, THERE WAS MORE DRAINAGE IN THE JP; NOT QUITE BLOOD BUT A LITTLE MORE. SERIAL HEMOGLOBIN WAS ORDERED AND CHECKED EVERY SIX HOURS. THE H/H WAS STABLE THROUGHOUT THE DAY. DURING THE NIGHT THERE WAS MASSIVE BLEEDING. THE ON-CALL SURGEON WAS CALLED BUT BY THE TIME HE GOT THERE THE PATIENT WAS IN CARDIAC ARREST. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM. HEMOPERITONEUM WAS FOUND. THE PATIENT HAD THREE LITERS OF BLOOD IN THE ABDOMEN. THERE WAS NO TRAUMA ON THE SPLEEN, NO ACTIVE BLEEDING. THE GUESS IS IT WAS COMING FROM THE SPLENIC HILUM. THE BLOOD WAS IN THE PANCREATIC BED. WHEN USING THE GIA DOES NOT BLEED BACK. THE PATIENT DID NOT MAKE IT. DID YOU SEE GENERATOR ERRORS? PER THE SURGEON, WORKED AT THE BEGINNING AROUND AN HOUR, MESSAGE GIVEN TO REPLACE THE DEVICE; TISSUE WAS IN THE JAWS. IT WAS JUST ON THE TISSUE, NOT UNDER WATER. UNPLUGGED AND THE MESSAGE WENT AWAY. IS IT STANDARD PROCEDURE TO UNPLUG AND RE-PLUG? PER THE SURGEON, NO. THIS IS THE FIRST TIME I RECEIVED THIS ERROR. EXPLANATION PER ENGINEER REGARDING THE GENERATOR ANALYSIS: THERE WAS A SHORT CIRCUIT. THE ERROR WAS GIVEN AND THE DEVICE WILL NOT ACTIVATE. IF YOU RECEIVE THREE ERRORS IN A ROW, IT IS A SAFETY FOR THE DEVICE AND GIVES THE REPLACE INSTRUMENT ERROR. UNPLUGGING AND RE-PLUGGING OVER RIDES THIS SAFETY AND RESETS THE COUNTER. THIS ERROR WAS SEEN FOUR TIMES (REPLACE INSTRUMENT); INDICATING THAT THERE WAS SOMETHING WRONG WITH THE DEVICE AND IT NEEDED TO BE REPLACED. PER THE SURGEON: THE ERROR MESSAGE REPLACE INSTRUMENT WAS NOT CLEAR ENOUGH AND I THOUGHT THAT I MISUSED THE DEVICE. I WAS QUESTIONING TO REPLACE THE DEVICE. ENGINEER PROVIDED ADDITIONAL INFORMATION ON THE ERROR MESSAGES. CLOSING ON METALLIC OR ON SOMETHING CONDUCTIVE WILL CAUSE THIS ERROR OR DAMAGE TO THE JAW OR THICK TISSUE. DID YOU FEEL A DIFFERENCE IN THE GRASPING WITH THE DEVICE? PER THE SURGEON: NO, GRASPING WAS ADEQUATE. DID YOU SEE A CHANGE IN THE TISSUE EFFECT? PER THE SURGEON: NO, WHEN WORKING IT WAS FINE. WHEN YOU RECEIVE THESE ERRORS, DO NOT UNPLUG AND RE-PLUG. THE SURGEON CONFIRMED THAT HE DID COME TO MANUFACTURER FOR TRAINING AND HAS BEEN USING THE DEVICE FOR ABOUT A YEAR.
IT WAS REPORTED THAT DURING A DISTAL PANCREATECTOMY PROCEDURE, THERE WAS A PROBLEM WITH TWO DEVICES. DEVICE #1 - HAD MULTIPLE ERROR CODES, SUCH AS REPLACE INSTRUMENT, ETC. THEY UNPLUGGED AND RE-PLUGGED IN THE DEVICE. THERE WERE TONES ON GENERATOR, USED IT A BIT AND THEN THERE WAS NOTHING. THIS HAPPENED 2-3 TIMES. THE SURGEON WAS TAKING SMALL BITES OF TISSUE AND THERE WERE NO CLIPS PRESENT WHERE HE WAS WORKING. DEVICE WAS THEN USED EITHER ON THE SPLENIC VEIN OR A BRANCH OF THE SPLENIC VEIN, THE SURGEON COULD NOT SAY FOR SURE. THE DEVICE WAS ACTIVATED AND THE TWO TONES WERE HEARD. THERE WAS BLEEDING. HE TRIED TO CONTROL THE BLEEDING WITH THIS DEVICE, BUT COULD NOT. THEN TRIED TO CONTROL THE BLEEDING WITH CLIPS, BUT AGAIN WAS NOT ABLE TO DO SO. OPENED A COMPETITOR STAPLING DEVICE AND APPLIED A LINE OF STAPLES, THIS SEEM TO STOP THE BLEEDING. THE SITE WAS CLEANED TO CONFIRM HEMOSTASIS. THE SURGEON ASKED THE STAFF TO KEEP THE DEVICE, BUT IT WAS INADVERTENTLY DISCARDED. DEVICE #2 - A NEW DEVICE, SAME LOT, WAS OPENED AND USED TO COMPLETE THE CASE. THE PATIENT WAS GIVEN A DRAIN. THIS DEVICE WAS ALSO DISCARDED.DUE TO THE DIFFICULTIES EXPERIENCED DURING THE CASE THE PATIENT WAS SENT TO INTENSIVE CARE FOR ADDITIONAL MONITORING. WHILE IN INTENSIVE CARE, THERE WAS NOTHING COMING FROM THE DRAIN. THE STAFF DID AN UNKNOWN TEST TO CHECK FOR BLEEDING AND THERE WERE NO SIGNS OF BLEEDING. DURING THE NIGHT THE PATIENT WAS NOT DOING WELL, WENT INTO SHOCK AND WAS BROUGHT BACK TO THE OPERATING ROOM FOR A REOPERATION. THE SURGEON COULD NOT TELL WHERE THE BLEEDING WAS COMING FROM. THE SPLEEN WAS REMOVED AND HE COULD SEE THE STAPLING LINE AND THE CLIPS BUT WAS UNABLE TO COUNT IF THEY WERE ALL THERE. THE PATIENT DID NOT SURVIVE. THE SURGEON CANNOT ATTRIBUTE THE PATIENT'S DEATH TO A PARTICULAR DEVICE, BUT CANNOT RULE OUT ANY OF THE DEVICES EITHER. ALL DEVICES IN THE CASE WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154929 | ENSEAL G2 STRAIGHT JAW | ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES | GEI | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |