BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 3835293 · Received May 28, 2014

    Report

    Report Number
    3005075853-2014-03582
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED. HAVE THESE COMPLAINTS BEEN REPORTED PREVIOUSLY? CAN WE OBTAIN PATIENT SPECIFIC INFORMATION FOR THESE 4 PATIENTS? REGARDING THE POST-SURGICAL COMPLICATION OF THE PARALYSIS OF THE RECURRENT LARYNGEAL NERVE (RLN): PARALYSIS OF THE RECURRENT LARYNGEAL NERVE CONTINUING FOR 6 MONTHS IS CONSIDERED PERMANENT WAS THE PARALYSIS TEMPORARY OR PERMANENT? WAS THE THYROIDECTOMY A TOTAL THYROIDECTOMY? WAS THE USAGE OF THE FCS9 DIRECTLY ATTRIBUTED TO THE PARALYSIS OF THE RECURRENT LARYNGEAL NERVE (RLN) FOR THESE TWO PATIENTS? OR WAS THE PARALYSIS OF THE RECURRENT LARYNGEAL NERVE DUE TO ANOTHER REASON AND NOT ATTRIBUTED TO THE USAGE OF THE FCS9 FOR SURGERY? HOW LONG AFTER THE THYROIDECTOMY DID THE PATIENTS PRESENT WITH THE VOCAL CORD PARALYSIS? WHAT DID THE PATIENT PRESENT WITH? POSTOPERATIVE HOARSENESS OR BREATHINESS; BIPHASIC STRIDOR, RESPIRATORY DISTRESS, OR BOTH; AIRWAY SIGNS IN THE IMMEDIATE POSTOPERATIVE PERIOD; DYSPNEA OR STRIDOR WITH EXERTION; AN INABILITY TO CREATE A HIGH-PITCHED SOUND. WAS THE PATIENT DIAGNOSED WITH LARYNGEAL NERVE DAMAGE? WAS THE PATIENT DIAGNOSED WITH UNILATERAL VOCAL FOLD PARALYSIS? WAS THE PATIENT DIAGNOSED WITH BILATERAL VOCAL-FOLD PARALYSIS WHAT TYPE OF DAMAGED WAS THE PATIENT DIAGNOSED WITH? COMPLETE OR PARTIAL TRANSECTION; TRACTION; CONTUSION; CRUSH; BURN; MISPLACED LIGATURE; COMPROMISED BLOOD SUPPLY. WHEN DIAGNOSED, DID THE PATIENT HAVE A FIBEROPTIC LARYNGOSCOPY PERFORMED? DID THE PATIENT RECEIVE A LARYNGEAL ELECTROMYOGRAPHY (EMG) TO DISTINGUISH VOCAL FOLD PARALYSIS FROM INJURY TO THE CRICOARYTENOID JOINT SECONDARY TO INTUBATION. WHAT IS THE PATIENT¿S CURRENT CONDITION? WHAT TREATMENT WILL BE PATIENT BE RECEIVING? REGARDING THE POST-SURGICAL COMPLICATION OF DYSPNEA, WHICH IS SHORTNESS OF BREATH: MANY THYROID DISEASES CAN LEAD TO PULMONARY PROBLEMS, INCLUDING HYPOTHYROIDISM, HYPERTHYROIDISM, NODULAR GOITER, AND THYROID CANCER. BOTH HYPOTHYROIDISM AND HYPERTHYROIDISM CAUSE RESPIRATORY MUSCLE WEAKNESS AND DECREASE PULMONARY FUNCTION. HYPOTHYROIDISM REDUCES RESPIRATORY DRIVE AND CAN CAUSE OBSTRUCTIVE SLEEP APNEA OR PLEURAL EFFUSION, WHILE HYPERTHYROIDISM INCREASES RESPIRATORY DRIVE AND CAN CAUSE DYSPNEA ON EXERTION. COMPRESSION OF THE TRACHEA, WHICH MAY BE POSITIONAL, CAN OCCUR WITH NODULAR GOITERS AND THYROID CANCER, AND THE LATTER CAN METASTASIZE TO THE LUNGS. WAS THE POST-SURGICAL COMPLAINT OF DYSPENEA DIRECTLY ATTRIBUTED TO USAGE OF THE FCS9 FOR SURGERY? REGARDING THE POST-SURGICAL COMPLICATION OF TETANY: TETANY IS A MEDICAL SIGN CONSISTING OF THE INVOLUNTARY CONTRACTION OF MUSCLES, WHICH MAY BE CAUSED BY DISEASE OR OTHER CONDITIONS THAT INCREASE THE ACTION POTENTIAL FREQUENCY OF MUSCLE CELLS OR THE NERVES THAT INNERVATE THEM. HYPOCALCEMIA IS THE PRIMARY CAUSE OF TETANY. UNDERFUNCTION OF THE PARATHYROID GLAND CAN LEAD TO TETANY WAS THE POST-SURGICAL COMPLAINT OF TETANY DIRECTLY ATTRIBUTED TO USAGE OF THE FCS9 FOR SURGERY?

    Description of Event or Problem · 1

    DURING A JOURNAL ARTICLE REVIEW BY YU YINGJUAN ENTITLED: APPLICATION OF ULTRASONIC SCALPEL IN THYROIDECTOMY IN (B)(6) MODERN DOCTOR (B)(6) 2012 VOL 50 NO. 17, THE ARTICLE REFERENCES THAT FROM (B)(6) 2009 TO (B)(6) 2011, 93 OF 186 PATIENTS WITH THYROID DISEASES RECEIVED ULTRACISION SCALPEL SURGERY. POST-SURGICAL COMPLICATIONS FOR PATIENT IN THE STUDY GROUP WHERE THE FCS9 DEVICE WAS USED WERE: 1 PATIENT WITH DYSPNEA; 2 PATIENTS WITH PARALYSIS OF RLN AND 1 PATIENT WITH TETANY. "THE POST-SURGICAL COMPLICATIONS OF THE TWO GROUPS WERE COMPARED AND SHOWED STATISTICALLY SIGNIFICANT DIFFERENT (P LESS THAN 0.05)." FEWER COMPLICATIONS FOR PATIENTS RECIEVING SURGERY WITH THE FCS9 DEVICE. " THE CASE NUMBER OF RECURRENT LARYNGEAL NERVE INJURY BETWEEN 2 SURGICAL GROUPS DID NOT SHOW THE STATISTICALLY SIGNIFICANT DIFFERENCE (P GREATER THAN 0.05)." "IN THIS STUDY, THE INCIDENCE OF RECURRENT LARYNGEAL NERVE INJURY IN TWO DIFFERENT SURGICAL GROUPS DID NOT SHOW THE STATISTICALLY SIGNIFICANT DIFFERENCES, SIGNIFYING THAT THE ULTRACISION SCAPEL [SIC] DID NOT INCREASE THE DAMAGE TO RECURRENT LARYNGEAL NERVE." IN CONCLUSION, THE APPLICATION OF ULTRACISION SCAPEL IN OPEN THYROIDECTOMY HAS THE ADVANTAGES OF SMALL INCISION, FAST REHABILITATION, AND LOWER INCIDENCE OF COMPLICATIONS. THE SKILLFUL OPERATION CONTRIBUTES THE REDUCTION OF OCCURRENCE OF RECURRENT LARYNGEAL NERVE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314011 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE