BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6178262 · Received December 15, 2016

    Report

    Report Number
    3005075853-2016-07078
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 2, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ADDITIONAL INFORMATION PROVIDED WAS REVIEWED BY COMPANY MEDICAL SAFETY OFFICERS, BOTH SURGEONS. BASED ON THEIR REVIEW, IT WAS DETERMINED THAT THE REPORTED EVENTS WERE COMPARING AIR LEAK RATES IN POST-OPERATIVE VATS LOBECTOMY PROCEDURES BASED ON THE TIME IN WHICH THE CHEST TUBE WAS REMOVED. THERE WAS NO ALLEGED QUALITY ISSUE WITH THE REPORTED DEVICE. THE CUSTOMER STATED IT WAS CONCLUDED THAT THE TYPE OF PNEUMOSTAT DRAIN USED ON DISCHARGED PATIENT WAS THE LIKELY CONTRIBUTING FACTOR OF THE AIR LEAK. BASED ON CONCLUSION, THE REPORTED EVENT DOES NOT MEET THE FDA CRITERIA OF A COMPLAINT AND MDR EVENT. ADDITIONAL INFORMATION RECEIVED: OUR AIR LEAK RATE IS ACTUALLY 32% WITH ERAS AS COMPARED TO 40% PREVIOUSLY FOR POD #1 & 2. SO IT WAS ACTUALLY A MISPERCEPTION AS TO OUR LEAK RATE. ALSO THE PROBLEM WAS PROBABLY MORE RELATED TO THE PNEUMOSTAT DRAIN WE USED ON DISCHARGE WHICH WE HAVE CORRECTED BY CHANGING TO AN ATRIUM OR TELEFLEX DRAIN. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHAT COLOR AND PRODUCT CODES OF CARTRIDGES WERE USED? ECR60W, ECR60B, ECR60G. SURGEONS STATED FISSURES WERE THIN ENOUGH FOR ECR60W FIRING. WAS BUTTRESSING MATERIAL USED? THEY DO NOT USE BUTTRESS MATERIAL. HAVE ALWAYS HAD GREAT OUTCOMES WITHOUT IT. WHAT DAY POST-OP WAS CHEST TUBE REMOVED? 68% OF THE PATIENTS HAD THEIR CHEST TUBES REMOVED POD#1 OR SAME DAY IF THEY HAD A WEDGE RESECTION. THE ONES WITH AIR LEAKS WERE SENT HOME WITH THE CHEST TUBE IN AND RETURNED FOR CHEST TUBE REMOVAL POD 3 OR 4 OR WITHIN A WEEK PREVIOUSLY. NOW WE SEE EVERYONE BACK AT 3 DAYS POST DISCHARGE. WHAT IS THE SURGEON¿S STANDARD PROCEDURE PRIOR TO CHEST TUBE BEING REMOVED? PRIOR TO CHEST TUBE REMOVAL WE GET AN XRAY AND CHECK THAT THERE¿S NO AIR LEAK. MOST PATIENTS GET A CXR AFTER REMOVAL BEFORE DISCHARGE HOME. HOW WAS THE PATIENT TREATED POST-OP? POST OP THE PATIENTS AMBULATE IN PACU AND HOURLY ON THE WARD. THEY ALL BEGIN WITH -20 SUCTION ON THE TUBE TO EVACUATE THE IATROGENIC PNEUMOTHORAX AND ARE SWITCHED TO UNDERWATER SEAL ONCE ON THE WARD DOES THE SURGEON PUT CHEST TUBES IN POST-OP ROUTINELY? ALL PATIENTS HAVE A CHEST TUBE POST OP. WHAT IS THE CURRENT PATIENT STATUS? ALL PATIENTS HAVE NOW HAD THEIR TUBES REMOVED AND HAVE RECOVERED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS ASSUMED FIRST DAY OF THE MONTH (MONTH) THAT THE COMPLAINT WAS RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE: WHAT COLOR AND PRODUCT CODES OF CARTRIDGES WERE USED? WAS BUTTRESSING MATERIAL USED? WHAT DAY POST-OP WAS CHEST TUBE REMOVED? WHAT IS THE SURGEON¿S STANDARD PROCEDURE PRIOR TO CHEST TUBE BEING REMOVED? HOW WAS THE PATIENT TREATED POST-OP? DOES THE SURGEON PUT CHEST TUBES IN POST-OP ROUTINELY? WHAT IS THE CURRENT PATIENT STATUS? ADDITIONAL INFORMATION RECEIVED FROM SURGEON AT HOSPITAL: WE'VE LOOKED INTO THE NUMBERS AND AS IT TURNS OUT, PRIOR TO ERAS WE HAD 40% AIR LEAK RATE AT POD #1. NOW OUR AIR LEAK RATE FOR POD#1 IS ACTUALLY LOWER AT 20-25%. SO WE'RE ACTUALLY DOING PRETTY WELL. THE PROBLEM HAS BEEN DEALING WITH THE CHEST TUBES AT HOME WHICH WE'RE WORKING ON WITH NEW DRAINAGE UNITS. WE'RE PULLING THE NUMBERS FOR POD#2-4 SO WE'LL SEE WHAT THE DIFFERENCES ARE. I'LL KEEP YOU POSTED. REP SAYS: THIS IS VERY GOOD NEWS FOR THEIR PROGRAM. THEY STARTED THEIR ERAS (ENHANCED RECOVERY AFTER SURGERY) PROGRAM IN (B)(6) 2016-TIME FRAME AND ALREADY POSITIVE RESULTS FOR POD#1 (POST OP DAYS). THIS PROGRAM HAS A DETAILED PRE-OP, DURING AND POST-OP PROTOCOL, ALL IN THE GOAL OF ENHANCING CARE AND PRODUCING ENHANCED PATIENT OUTCOMES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING FIVE VATS LOBECTOMY PROCEDURES (2X UPPER LEFT; 1X UPPER RIGHT 1X LOWER RIGHT; 1X LOWER LEFT), THE PATIENT'S HAD AIR LEAKS. THIS OCCURRED OVER A THREE WEEK PERIOD IN (B)(6) 2016. THERE ARE THREE DIFFERENT SURGEON'S INVOLVED. THE PATIENT'S RANGED IN AGE BETWEEN 55 TO 60 YEARS OLD, AND HAD EMPHYSEMA. THE SURGERIES WERE TO REMOVE CANCEROUS TUMOURS. THERE WAS NO EXTREME TUMOUR PRESENTATIONS IN ANY OF THE PATIENTS. THE SURGERIES WERE UNEVENTFUL AND WERE CONDUCTED USING THEIR STANDARD PROCEDURAL APPROACH. STAPLE LINES APPEARED COMPLETE PRIOR TO CLOSING THE PATIENTS. NO REOPERATIONS WERE REQUIRED; ALL PATIENTS WERE GIVEN DRAINAGE CHEST TUBES. TWO OF THE PATIENT'S HAD TO RETURN TWICE WITH CHEST TUBES. ONE OF THE LEAKAGES WAS DETECTED RIGHT AWAY WHILE THE PATIENT WAS IN RECOVERY, FOR THE OTHERS IT IS UNKNOWN HOW LONG AFTER THE PROCEDURES THE LEAKAGES OCCURRED. PATIENTS WERE EITHER STABLE OR DISCHARGED FOLLOWING THE PROCEDURES. UNABLE TO EQUATE REPORTED EVENTS TO A PARTICULAR PATIENT, THEREFORE FIVE FILES WILL BE OPENED. NO LOT NUMBERS OR DEVICES WERE RETAINED, THE FACILITY IS UNABLE TO CONFIRM LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826960 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ECR60W, ECR60B, ECR60G