BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAC BLADE #2

    MDR report key: 1408795 · Received June 19, 2009

    Report

    Report Number
    2242551-2009-00003
    Event Type
    Other
    Date Received
    June 19, 2009
    Date of Event
    May 8, 2009
    Report Date
    June 18, 2009
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CCW
    PMA / PMN Number
    K905273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS RECEIVED FOR INVESTIGATION. VISUAL EXAMINATION OF THE SAMPLE SHOWED THAT THE BLADE HAD BROKEN AT THE BASE WHERE IT CONNECTS TO THE HANDLE/PIN. WHEN VIEWED UNDER MAGNIFICATION, THE BROKEN BLADE SHOWED EVIDENCE OF EXCESS FORCE AND APPEARED TO BE OVERSTRESSED. REVIEW OF RECEIVING/TEST DATA FOR PRODUCT, INCLUDING PRODUCT RECEIVED BEFORE AND AFTER THE SUSPECTED LOT NUMBER, REVEALED NO UNUSUAL OBSERVATIONS OR PROBLEMS AND ALL PRODUCT WAS WITHIN SPEC. NORMAL BREAK FORCES FOR VSI LARYNGOSCOPE 4502 & 4503 BLADES (B)(4) MEET OR EXCEED 35 & 40 LBS. AS PUBLISHED IN ANESTHESIOLOGY 65:107, 1986, "THE FORCE DURING A ROUTINE INTUBATION HAS BEEN MEASURED AS ROUGHLY 10 - 30 NEWTONS, APPROX EQUIVALENT TO 1 - 3 KILOGRAMS FORCE; BUT DURING DIFFICULT INTUBATIONS, THIS FORCE CAN INCREASE TO AS MUCH AS 100 NEWTONS OR APPROX 10 KILOGRAMS-FORCE (22 LBS FORCE)." VSI BLADES ARE WELL WITHIN THIS SPEC. THE RESULTS FROM THE DESTRUCTIVE TESTING PERFORMED AT TIME OF RECEIPT ARE USED FOR TRENDING PURPOSES ON THE LARYNGOSCOPE BLADE PRODUCT LINE. RETENTION SAMPLES ARE KEPT FOR EACH LOT. THE FAILURE MODE REPORTED (AT THE BASE NEAR THE HANDLE CONNECTION) HAS NOT BEEN CONFIRMED BY THE ACCOUNT, HOWEVER, THIS FAILURE MODE IS TYPICAL OF OUR INTERNAL DESTRUCTIVE TESTING RESULTS AND THE EXPECTED FAILURE MODE WHEN STRESSED BEYOND ITS PREDETERMINED LIMITS. THE LITERATURE SUGGEST THAT THE INTUBATION TECHNIQUE CAN BE A DIFFICULTY PROCEDURE REQUIRING MUCH SKILL AND EXPERIENCE, WITH EVENT THE MOST SKILLFUL PRACTITIONERS SOMETIMES FINDING IT EITHER DIFFICULTY OR IMPOSSIBLE TO INTUBATE CERTAIN INDIVIDUALS. THE VARIETY OF ANATOMIC DIFFERENCES PRESENTED BY PTS TO THE TRAINED CAREGIVER REPRESENT A POTENTIAL CHALLENGE WITH EACH NEWLY ATTEMPTED INTUBATION. FOR THIS REASON, THE AMERICAN SOCIETY OF ANESTHESIOLOGIST (ASA) HAS PUBLISHED: "PRACTICE GUIDELINES FOR MANAGEMENT OF THE DIFFICULTY AIRWAY" AS REFERENCED IN ANESTHESIOLOGY (78:597-602, 1993). THESE GUIDELINES SUGGEST ASSESSMENT OF THE AIRWAY, PREDETERMINING A STRATEGY FOR DEALING WITH DIFFICULTY AIRWAYS AND THE IMPLEMENTATION OF VARIOUS STRATEGIES THAT MAY INCLUDE LARYNGOSCOPE BLADES SUCH AS THE ONE IN QUESTION. THE UNIQUE COMBINATIONS FOR ANATOMIC DIFFICULTIES PRESCRIBED BY THE PT, INCLUDING BUT NOT LIMITED TO ANTERIORLY POSITIONED LARYNX. OBESITY, REDUCED ORAL CAVITY, PROTRUDING TEETH, TRAUMA, LARYNGOSCOPIC VIEW, FLEXION OF THE ATLANTOOCCIPITAL JOINT, THYROMENTAL DISTANCE, ETC., MAY INDICATE THAT A CERTAIN TYPE BLADE (MILLER, MACINTOSH, ETC.) BE UTILIZED. THE GUIDELINES ALSO SUGGESTS THAT DIRECT LARYNGOSCOPY (WITH EITHER PLASTIC OR METAL BLADES) MAY NOT BE THE BEST STRATEGY FOR ALL PTS AND WHEN THIS SITUATION IS DETERMINED, OTHER DEVICES MAY BE EMPLOYED TO MANAGE THE AIRWAY, SUCH AS LIGHT WAND, STYLET OR FLEXIBLE FIBEROPTIC. DUE TO ANY VARIETY OF THE ABOVE MENTIONED FACTORS, THERE WILL BE OCCASIONS WHEN AN INTUBATION ATTEMPT IS UNSUCCESSFUL THROUGH NO FAULT OF THE "INTUBATION SYSTEM" CHOSEN. ANY POTENTIAL "FAILURE" OF THE COMPONENTS OF HIS SYSTEM, MAY, IN FACT, BE THE OUTCOME OF THESE DIFFICULTIES AND NOT NECESSARILY SHORTCOMINGS OF THE DEVICE IN QUESTION. INITIAL INFO THAT THE BLADE BROKE NEAR THE HANDLE CONNECTION IS TYPICAL OF OUR INTERNAL DESTRUCTIVE TESTING RESULTS AND THE EXPECTED FAILURE MODE WHEN STRESSED BEYOND ITS PREDETERMINED LIMITS. SINCE A REVIEW OF INCOMING INSPECTION AND TEST DATA INDICATE THAT LOT NUMBERS RECEIVED AROUND THE TIME OF THE SUSPECT BLADE REVEALED NO PROBLEMS AND THAT ALL BLADES MEET OR EXCEED SPEC BREAK RESULTS, WE BELIEVE THAT THIS INCIDENT MAY BE THE RESULT OF EXCESSIVE FORCE USED ON THE BLADE DURING A DIFFICULT INTUBATION. EXAMINATION OF THE RETURNED SAMPLE PROVIDED BY THE ACCOUNT INDICATED THAT THE BLADE BROKE AT THE BASE WHERE IT CONNECTS THE HANDLE/PIN. THE REMAINING SECTION OF BLADE SHOWED NO DAMAGE, CRACKS, OR BREAKAGE. BASED ON OVER 15 YEARS EXPERIENCE, THIS TYPE OF BREAK IS TYPICAL OF EXCESSIVE FORCE USED ON THE BLADE DURING INTUBATION. FORCES IN EXCESS OF 35-40 LB ARE REQUIRED TO CAUSE THIS TYPE OF BREAK. THERE WAS NOT PT INJURY. THE SAMPLE WAS RETURNED AND THE COMPLAINT HAS BEEN CONFIRMED AS REPORTED. BASED ON THE INFO AVAILABLE, WE BELIEVE THAT THE INCIDENT IS THE RESULT OF EXCESSIVE FORCE USED BY THE CLINICIAN DURING THE INTUBATION; EXPERIENCE AND TEST RESULTS INDICATE THAT MORE THAN 35-40 LB OF FORCE ARE REQUIRED TO BREAK THE BLADE AT THE HANDLE CONNECTION. THIS WAS NOT THE RESULT OF PRODUCT MALFUNCTION OR DEFECT. THIS INCIDENT IS CONSIDERED ISOLATED AND UNUSUAL.

    Description of Event or Problem · 1

    EVENT DESC: LARYNGOSCOPE BLADE BROKE DURING ATTEMPT AT PT INTUBATION. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAC BLADE #2 LARYNGOSCOPE BLADE CCW VITAL SIGNS, INC. NA 058E

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR