55MM SELECTABLE NEW TLC
Report
- Report Number
- 3005075853-2011-01771
- Event Type
- Death
- Date Received
- April 28, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 13, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K092577
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
(B)(4). DATE SENT: (B)(4) 2011. INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011: AN EMERGENCY SURGERY WAS A RESULT OF A LEAK FROM THE (B)(4) USED IN THE PREVIOUS PROCEDURE. HOWEVER, WHEN DISCUSSED WITH THE REGISTRAR, HE DESCRIBED THAT THE LEAK APPEARED TO HAVE BEEN FROM TWO POINTS ON THE (B)(4) STAPLE LINE NOT THE (B)(4), ALTHOUGH COULDN'T BE 100% SURE. HIS INSPECTION OF THE STAPLE LINE POST FIRING OF THE (B)(4) WAS CONSISTENT AND HE HAD HOPED THAT THIS STAPLE LINE WOULD BE SUPERIOR TO THE PREVIOUS STAPLE LINE WHICH HE EXPERIENCED THE LOCK OUT ON. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011: THE (B)(4) WAS FIRED TO FORM ANOTHER SIDE TO SIDE ANASTOMOSIS AFTER THE MISFIRE OCCURRED. THIS COULD BE THE (B)(4); HOWEVER, THEY HAVE RAISED THE COMPLAINT AGAINST THE (B)(4). THE REGISTRAR REFERRED TO THE (B)(4) STAPLE LINE LEAKING IN TWO PLACES.
(B)(4). ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING RESPONSE RECEIVED ON (B)(6) 2011: ASKED FOR THE PATIENT'S CAUSE OF DEATH. THE SURGEON'S REPLY WAS: 'AS FAR AS I REMEMBER, IT IS SEPSIS SECONDARY TO BOWEL PERFORATION.'
(B)(4). THE ANALYSIS RESULTS FOUND THAT THE NTLC55 DEVICE WAS RECEIVED WITH THE KNIFE FULLY EXPOSED AND THE FIRING KNOB DETACHED. THE DEVICE WAS RECEIVED WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RETURNED FULLY FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED. AFTER FURTHER ANALYSIS AND REVIEW OF THE INFORMATION REPORTED, IT HAS BEEN CONCLUDED AS FOLLOWS: BASED ON THE EVENT DESCRIPTION AND CONDITION OF THE RETURNED DEVICE, THERE IS A HIGH LIKELIHOOD THAT THE SURGEON ATTEMPTED TO FIRE THE DEVICE BEYOND THE 55MM STOP, THUS BREAKING THE FIRING KNOB OFF OF THE DEVICE. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. IN ADDITION, PLEASE NOTE THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE.
(B)(4). FIRING KNOB DISLODGED ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING RESPONSE RECEIVED: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC) DURING THE ORIGINAL PROCEDURE? THE MISFIRE OCCURRED ON THE 1ST FIRING. WHAT COLOR (BLUE/GOLD/GREEN) WAS SELECTED ON THE SELECTABLE STAPLE HEIGHT SELECTOR BEFORE FIRING? BLUE, NO CHANGE WAS MADE. WAS THE CARTRIDGE LOADED WITH THE RETAINING CAP ON? NO. DID THE SURGEON MOVE THE FIRING KNOB TO THE LEFT OR TO RIGHT BEFORE FIRING? NO, HAD BEEN MADE AWARE OF THIS AND WAS CONSCIOUS NOT TO MOVE THE TRIGGER UNTIL READY TO INITIATE THE FIRING. WAS THE HANDLE CLOSED COMPLETELY BEFORE FIRING? YES. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? THE NTLC55 WAS NOT, HOWEVER THE TLC55 WOULD HAVE BEEN FIRED NEAR THE STAPLE LINE CREATED BY THE NTLC55. WERE ANY UNEXPECTED NOISES HEARD? NO NOISES WERE HEARD, THE DEVICE JUST JAMMED WITHOUT COMPLETING THE FIRST FIRING WITHOUT ANY NOISES BEING HEARD. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO, ALTHOUGH NOTED THE KNIFE WAS PROTRUDING AT THE DISTAL END OF THE DEVICE. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? THE DEVICE HAD BEEN USED APPROXIMATELY 2-4 TIMES PREVIOUSLY. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? THIS WAS A PRODUCT UPGRADE FROM THE TLC TO THE NTLC. WHAT PREDICATE DEVICE WAS USED BY THE SURGEON? UNCLEAR OF WHAT IS BEING REQUESTED HERE, PLEASE CLARIFY. IN ADDITION TO CANCER, WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? PATIENT WAS FRAIL, SHE HAD PREVIOUS OPERATIONS TO INCLUDE RIGHT HEMICOLECTOMY, SIGMOID COLECTOMY, ILLEOSTOMY REVERSAL, ADHESIONS AND RENAL FAILURE. WHAT TYPE AND STAGE OF CANCER DID THE PATIENT HAVE? UNABLE TO RECALL THE STAGE OF CANCER. DOES THE PATIENT HAVE A HISTORY OR RECEIVING RADIATION OR CHEMOTHERAPY? NO RADIATION, BUT POSSIBLY CHEMOTHERAPY. WHAT WAS THE QUALITY OF THE TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? THE QUALITY OF THE TISSUE WAS ACCEPTABLE, BUT (B)(6) NOTED THE CONDITION OF THE BOWEL TO BE FRAGILE DURING THE EMERGENCY PROCEDURE. THE PROCEDURE WAS REPORTED TO BE AN ILEOSTOMY REVERSAL? WAS ANY ADDITIONAL PROCEDURE PLANNED TO BE COMPLETED AT THE SAME TIME? NO. AFTER THE ILEOSTOMY REVERSAL CASE WAS STARTED, DID THE SURGEON INDICATE THAT THE PATIENT'S CONDITIONS HAD DETERIORATED SINCE THE ILEOSTOMY WAS FIRST GIVEN? NO. WHAT WAS THE AGE AND SEX OF THE PATIENT? (B)(6) AND FEMALE. WAS AN AUTOPSY COMPLETED? NO. IF SO, IS IT AVAILABLE? NO. CAN YOU CONFIRM THAT THE SURGEON DID NOT HAVE PRODUCT TRAINING PRIOR TO HIM USING THE DEVICE? THE SURGEON WAS NOT TRAINED BY ME PRIOR TO USING THE DEVICE. WOULD THE SURGEON BE WILLING TO HAVE A PEER TO PEER CONVERSATION WITH AN EES CONSULTANT SURGEON? NOT NECESSARY. BASED ON THE INFORMATION PROVIDED, ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING RESPONSE RECEIVED: CAN YOU CONFIRM THAT THIS CUSTOMER RECEIVED TRAINING AT ALL? THE SURGEON HAS OVERSEEN TRAINING CONDUCTED WITH (B)(6) (CONSULTANT SURGEON) BY ME, BUT THIS TRAINING WAS FOCUSED ON (B)(6) WHO WAS DUE TO USE THE NTLC ON A LIVE CASE. HOWEVER HE HAS SUBSEQUENTLY RECEIVED TRAINING. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE KNIFE FULLY EXPOSED AND THE FIRING KNOB DETACHED. THE DEVICE WAS RECEIVED WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RETURNED FULLY FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE FIRING KNOB BECAME DAMAGED, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. IN ADDITION, PLEASE NOTE THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.
IT WAS REPORTED THAT DURING A SIDE-TO-SIDE ANASTOMOSIS, THE FIRING TRIGGER BROKE AS A RESULT OF THE TRIGGER BECOMING STUCK AT THE DISTAL END OF THE FIRING PROCESS. THE TRIGGER JAMMED AND WOULD NOT ADVANCE FURTHER OR RETURN TO THE PROXIMAL END OF THE FIRING PROCESS. AFTER FURTHER PRESSURE APPLIED TO THE FIRING TRIGGER AND THE TRIGGER SEPARATED FROM THE DEVICE, THE (B)(4) WAS REMOVED FROM THE SEGMENT OF BOWEL TO REVEAL THE KNIFE STILL ADVANCED AND STAPLES LAID FURTHER THAN THE KNIFE HAD CUT. AN ORIGINAL (B)(4) WAS USED TO FINISH THE ANASTOMOSIS. INFORMED THAT THE PATIENT SUFFERED A LEAK IN TWO PLACES FROM THE STAPLE LINE; THIS SUBSEQUENTLY LED TO AN EMERGENCY PROCEDURE TAKING PLACE ON THE (B)(6) 2011. THE PATIENT DIED ON THE (B)(4) 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 55MM SELECTABLE NEW TLC | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death| O| R | CARTRIDGE |