BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE 1884012EM RAD12 4MM M4 ROTATE

    MDR report key: 2423723 · Received January 20, 2012

    Report

    Report Number
    1045254-2012-00006
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    December 22, 2011
    Report Date
    December 22, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THIS DEVICE WAS OUT OF SPECIFICATION IN AN "AS RECEIVED CONDITION." THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT ISSUE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST AND, THEREFORE, IS LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF THIS EVENT WERE TO RECUR. WITHOUT SERIOUS INJURY OR INTERVENTION WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. ANALYSIS: THE ITEM SHOWED SIGNS OF USE, INCLUDING SMALL AMOUNT OF BLOOD ON THE OUTER TUBING. BLADE WAS BROKEN AT TIP, AND THE OUTER BLADE TIP WAS INCLUDED IN THE PACKAGING. THERE APPEARS TO BE NO MISSING PARTS. THE INNER BLADE WAS ABLE TO BE FREELY ROTATED MANUALLY. THE SPIRAL WRAP WAS UNWOUND AND APPEARS TO BE THE POINT OF FAILURE. WHEN INSPECTED UNDER 20X MAGNIFICATION, THE SPIRAL WRAP COULD BE SEEN TO BE SHEARED AT THE NARROWEST POINT OF THE WRAP, AT THE CORNER OF A DOVETAIL. VISUAL INSPECTION UNDER 20X MAGNIFICATION SHOWS A TYPICAL SPIRAL WRAP FAILURE, WITH SOME DISTENSION AND UNWINDING OF THE SPIRAL WRAP. SMALL AMOUNTS OF BONE WERE APPARENT WITHIN THE DOVETAILS OF THE FAILED SPIRAL WRAP. THE INNER BLADE IS CLEAR OF DEBRIS, AND APPEARS CLEAN. FURTHER INSPECTION OF THE CONNECTOR SHOWS DIMPLES ON THE LOWER HUB, PROXIMAL TO THE ROW OF SCALLOPED "TEETH." THIS COULD BE INDICATIVE THAT THE HANDPIECE WAS LOCKED DOWN ONTO THE BLADE WITH THE BLADE NOT SEATED PROPERLY, HOWEVER, WEAR MARKS ON THE SCALLOPING ALSO INDICATE THAT THE BLADE WAS RESEATED IN THE PROPER POSITION, AND LOCKED IN. (THE LOCKING HANDPIECE HAS THREE BALL BEARINGS THAT ARE PUSHED ONTO THE HUB TO LOCK IN. PROPER LOCKING POSITION WOULD PUT THESE BALL BEARINGS INTO THE SCALLOPED TEETH OF THE HUB.) THE MICRODEBRIDER SYSTEM IS DESIGNED TO ACCOMMODATE A NUMBER OF OTORHINOLARYNGOLOGY PROCEDURES, INCLUDING FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), ADENOIDECTOMY. A VARIETY OF DISPOSABLE BLADES AND BURS ARE AVAILABLE FOR THIS PURPOSE. INDICATIONS FOR USE SINUS INDICATIONS INCLUDE SEPTOPLASTY, REMOVAL OF SEPTAL SPURS, POLYPECTOMY, ANTROSTOMY, ETHMOIDECTOMY/SPHENOETHMOIDECTOMY, FRONTAL SINUS TREPHINATION AND IRRIGATION, FRONTAL SINUS DRILL OUT, ENDOSCOPIC DCR, TRANS-SPHENOIDAL PROCEDURES, MAXILLARY SINUS POLYPECTOMY, CIRCUMFERENTIAL MAXILLARY ANTROSTOMY, CHOANAL ATRESIA, SPHENOIDECTOMY, AND MEDIAL, LATERAL, AND POSTERIOR FRONTAL SINUSOTOMY. WARNINGS DO NOT CHANGE ACCESSORY WITH HANDPIECE RUNNING TO PREVENT LACERATION OF USER AND CROSS-CONTAMINATION THROUGH COMPROMISED GLOVE. DO NOT MODIFY ACCESSORIES USED WITH THE HANDPIECE. PERFORMANCE COULD BE DIMINISHED WITH MODIFIED ACCESSORIES. USE ADEQUATE IRRIGATION FROM A SEPARATE USER-PROVIDED IRRIGATING SOURCE. THE USE OF AN ACCESSORY WITHOUT IRRIGATION MAY CAUSE AN INORDINATE AMOUNT OF HEAT BUILDUP RESULTING IN THERMAL INJURY TO TISSUE. DISPOSABLE DEVICES ARE FOR SINGLE-USE ONLY. DO NOT ATTEMPT TO STERILIZE DISPOSABLE DEVICES. THE DISPOSABLES ARE PACKED STERILE AND NOT INTENDED FOR REPEAT USE. TO PREVENT CONTAMINATION, USE ONLY ONCE. INSERTION OF METAL OBJECTS IN BLADE OR BUR TIP MAY CAUSE THE BLADE OR BUR TO BREAK LEAVING FRAGMENTS IN THE WOUND. THE FRAGMENTS MAY BE DIFFICULT TO REMOVE, CAUSING IRRITATION, INFLAMMATION AND FOREIGN-BODY RESPONSE AT SURGICAL SITE. ALWAYS KEEP THE CUTTING TIP OF THE ACCESSORY AWAY FROM FINGERS AND LOOSE CLOTHING. PREVENT LACERATION OF USER AND CROSS-CONTAMINATION THROUGH COMPROMISED GLOVE. BENDING OR PRYING MAY BREAK THE BLADE OR BUR, CAUSING HARM TO PATIENT OR STAFF. OPERATE THE BLADE OR BUR ONLY AFTER THE APPROPRIATE ANATOMICAL LANDMARKS AND THE INTENDED SURGICAL SITE HAVE BEEN CONFIRMED. BLADES, BURS AND IRRIGATION TUBING ARE DISPOSABLE AND INTENDED FOR SINGLE-USE ONLY, UNLESS OTHERWISE MARKED. TEST FOR WOBBLE AT DESIRED SPEED PRIOR TO USE. DISCONTINUE USE OF ACCESSORY IF TIP BEGINS TO WOBBLE AND REPLACE ACCESSORY TO PREVENT UNINTENDED TISSUE REMOVAL FROM PATIENT. BLADE AND BUR ACCESSORIES ARE AVAILABLE FOR RESECTION OF SOFT TISSUE AND BONE FOR SURGICAL PROCEDURES. USE OF ACCESSORIES DEPENDS ON THE INTENDED APPLICATION AND PATIENT NEEDS. SHARP-CUTTING POWERED ACCESSORIES INDUCE BLEEDING AND REMOVAL OF SIGNIFICANT TISSUE AND BONE. USE CARE IN APPLICATION OF THE MOVING CUTTING END TO ONLY APPROPRIATE ANATOMICAL LANDMARKS AND THE INTENDED SURGICAL SITE WHEN USING ACCESSORIES. THE USE OF POWERED RECIPROCATING/ROTATING INSTRUMENTS MAY RESULT IN VIBRATION-RELATED INJURY. USE APPROPRIATE PRECAUTIONS. EMPLOY VISUALIZATION WHEN USING ROTATING ACCESSORIES, INCLUDING USE OF IMAGE GUIDED SURGERY SYSTEM IF NEEDED. DISCONTINUE POWERED APPLICATION IN THE EVENT OF LACK OF VISUALIZATION OF THE SURGICAL SITE. USE METHODS AT THE OPERATIVE SITE TO CONTROL BLEEDING THAT DO NOT COMPROMISE PATIENT SAFETY DURING AT-RISK SURGERY. ALWAYS INSPECT THE COMPONENTS BEFORE AND AFTER USE FOR ANY DAMAGE. IF DAMAGE IS OBSERVED, DO NOT USE DAMAGED PART UNTIL IT IS REPLACED. DAMAGED PARTS MAY DEPOSIT METAL SHAVINGS ON SURGICAL SITE. DO NOT USE ANY PARTS OTHER THAN MEDTRONIC SYSTEM COMPONENTS AS DAMAGE OR SUBSTANDARD PERFORMANCE COULD RESULT. REMOVE AND DISCARD ACCESSORIES FOLLOWING LOCAL REGULATIONS FOR PROPER DISPOSAL OF CONTAMINATED MATERIALS. DO NOT USE ACCESSORY IF PACKAGE IS OPENED OR DAMAGED. BROKEN SEAL OFFERS NO PROTECTION AGAINST CROSS-CONTAMINATION. SURGICAL PRECAUTIONS TO PREVENT DAMAGE TO CURVED BLADES AND BURS, DISCONNECT SUCTION TUBE PRIOR TO CHANGING BLADE OR BUR DURING PROCEDURE. BE SURE THE BLADE IS FULLY ENGAGED IN THE MICRODEBRIDER AND VERIFY THE TIP IS FULLY ENGAGED WITH THE OUTER CANNULA PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    EVENT DESC: IT WAS REPORTED THAT DURING A SCHEDULED SINUS PROCEDURE, THE TIP OF A POWERED SINUS BLADE BROKE OFF IN THE PATIENT'S SINUS CAVITY. REPORTEDLY, THE INTERNAL PORTION OF THE CURVED BLADE WAS PULLED IN THE COURSE OF PERIOPERATIVE CLEANING. THE BLADE CONTINUED TO BE USED AND THE TIP BROKE IN THE PATIENT'S SINUS CAVITY, REQUIRING THE DETACHED SEGMENT TO BE REMOVED. A SECOND BLADE WAS USED IN THIS PROCEDURE WITH THE SAME INCIDENT OCCURRING; HOWEVER, THE SECOND BLADE WAS HYPEREXTENDED AND THERE WERE NO DETACHED FRAGMENTS. IT IS NOTED THAT THE POWERED HANDPIECE SPEED WAS 5000 RPM AND IRRIGATION WAS USED. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY. EXPIRATION DATE: 10/25/2013; BLADE 1884012EM RAD12 4MM M4 ROTATE (1884012EM/LOT IS UNKNOWN); (B)(4). DEVICE MANUFACTURE DATE: 11/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED SINUS PROCEDURE THAT THE TIP OF A POWERED SINUS BLADE BROKE OFF IN THE PATIENT'S SINUS CAVITY. TIP WAS RETRIEVED FROM THE PATIENT, NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE 1884012EM RAD12 4MM M4 ROTATE BUR, EAR, NOSE AND THROAT EQJ XOMED MFG JACKSONVILLE 1884012EM 0205530845

    Patients

    Seq Age Sex Outcome Treatment
    1