BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIS FORCEPS 4X5 155MM

    MDR report key: 6213928 · Received December 29, 2016

    Report

    Report Number
    9610612-2016-00015
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    September 3, 2016
    Report Date
    August 6, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DURING A CESAREAN SECTION SURGERY THE LEG OF THE ALLIS GRIPPER BROKE AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS LOCATED AND REMOVED FROM THE PATIENT AND SURGICAL FIELD. THERE WAS NO HARM TO THE PATIENT REPORTED. THERE WAS NO SURGICAL DELAY REPORTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE INSTRUMENT. HERE WE FOUND SCRATCHES AND GROOVES. ADDITIONALLY WE FOUND VISIBLE DAMAGE AND PITTING. FURTHERMORE, WE FOUND REDDISH BROWN CORROSION SPOTS. ADDITIONALLY WE MADE A VISUAL INSPECTION OF THE FRACTURE SURFACE. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY REPROCESSING OR USAGE RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD, A MATERIAL DEFECT OR PRODUCTION ERROR CAN BE EXCLUDED. WE ASSUME, DUE TO PITTING, STRESS CORROSION IN ADDITION WITH A MECHANICAL OVERLOAD SITUATION AS THE CAUSAL FACTOR. PITTING OR CORROSION HOLES MAY LEAD TO STRESS CORROSION CRACKING. WE ASSUME THAT THE DISCOLORATION ARE PINPRICK-LIKE CORROSION HOLES SURROUNDED BY SPARKLING, REDDISH BROWN OR MULTI-COLORED CORROSION SPOTS, OFTEN ASSOCIATED WITH CIRCULAR CORROSION DEPOSITS AROUND THE CORROSION HOLE. THE FOLLOWING POINTS COULD BE THE CAUSE OF THIS: EXPOSURE DUE TO HALIDE IONS (BROMIDES, IODIDES, AND CHLORIDES) BUT ESPECIALLY CHLORIDES THAT LOCALLY BREAK THROUGH THE PASSIVE LAYER OF THE INSTRUMENTS STEEL, THUS CAUSING PITTING. DRIED-ON ORGANIC RESIDUES, EG BLOOD, PUS, SECRETIONS. FREQUENT PITTING IS DUE TO THE USE OF LIQUIDS WITH HIGH CHLORIDE CONTENT, OR MORE SPECIFICALLY DUE TO DRY RESIDUES OF SUCH LIQUIDS ADHERING TO THE INSTRUMENT SURFACES. IF THE CONCENTRATION OF CHLORIDES IN THE FINAL RINSE WATER IS TOO HIGH, OR IF RESIDUES OF PHYSIOLOGICAL SALT SOLUTION REMAIN ON THE INSTRUMENT. BRAND NEW INSTRUMENTS ARE PARTICUALARLY SUSCEPTIBLE TO ATTACK BY MEDIA CONTAINING CHLORIDES DUE TO THEIR STILL THIN PASSIVE LAYER. INSTRUMENTS THAT HAVE BEEN USED FOR SOME TIME ARE MORE RESISTANT TO CHLORIDE ATTACK BECAUSE THEY HAVE DEVELOPED A THICKER PASSIVE LAYER. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863007 ALLIS FORCEPS 4X5 155MM GENERAL SURGICAL INSTRUMENTS HTD AESCULAP AG EA015R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other