BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]

    MDR report key: 3529351 · Received December 20, 2013

    Report

    Report Number
    9680837-2013-00505
    Event Type
    Injury
    Date Received
    December 20, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 25, 2013
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GCJ
    PMA / PMN Number
    K080257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: CEV649X5, TUBE D.5MM 35CM FOR ROTATABLE HANDLE (510K: K080257, LOT# 090401, MFR APRIL 2009). INSERT CEV625-1, FENESTRATED 350MM (510K: K993655, LOT# UNKNOWN). ACCORDING TO THE PRODUCT ANALYSIS REPORT: HANDLE CEV102910R DIA 10MM ANG W/RATCHET- NO ISSUE HIGHLIGHTED. INSTRUMENT CONFORMS TO MANUFACTURING SPECIFICATIONS. TUBE CEV649X5 DIA 5MM 350MM- WE HAVE OBSERVED AT THE PACKAGE RECEPTION: THE TUBE REF CEV649X5 IS BROKEN AT THE DISTAL SCREW THREAD LEVEL DESPITE THE DIMENSIONAL CONFORMITY OF THIS TUBE WITH OUR MANUFACTURING SPECIFICATIONS. THE TUBE REF CEV649X5 BELONGS TO BATCH 090401, WHICH HAS BEEN MANUFACTURED IN APRIL 2009. THE SCREW THREAD OF THE TUBE IS BROKEN. THE TUBE IS SLIGHTLY BENT. NO MANUFACTURING OR MATERIAL DEFECT HAS BEEN DETECTED AND THE THICKNESS OF THE SCREW THREAD CONFORMS TO MANUFACTURING SPECIFICATIONS. THE ORIGIN OF THE BREAKAGE IS PROBABLY AN ABNORMAL USE SUCH AS AN EXCESSIVE GRIP ON THE HANDLE, AN INSUFFICIENT SCREWING OF THE INSERT OR A SHOCK DURING USE OR REPROCESSING. INSERT CEV625-1 FENESTRATED 350MM- WE HAVE OBSERVED AT THE PACKAGE RECEPTION: THE INSERT REF CEV625-1 WAS PRESENTING SIGNIFICANT DEF ORMATIONS WHICH MADE IT UNFIT FOR IT NORMAL USE (INSERT BENT IN SEVERAL AREAS). THE JAWS OF THE INSERT REF CEV625-1 DO NOT PRESENT ANY TRAUMATIC PART WHICH COULD HAVE CAUSED THE REPORTED INJURIES. THE INSERT REF CEV625-1 HAS PROBABLY BEEN REPAIRED BY A NON-QUALIFIED EXTERNAL CONTRACTOR. THE INSERT IS STRONGLY BENT. THE MARKING HAS BEEN ERASED AND THE FINITION OF THE INSERT IS DIFFERENT FROM THE MANUFACTURING SPECIFICATIONS. NO TRAUMATIC PART HAS BEEN IDENTIFIED IN THE ACTIVE PART OF THE DEVICE. THE CAUSES OF THE TORSION ARE MOST LIKELY TO BE AN EXCESSIVE EFFORT OR CONSTRAINT DURING THE USE OF THE INSERT OR DURING THE REPROCESSING STEPS. THE ABSENCE OF ANY MARKING, AND THE DIFFERENT FINITION LETS US THINK THAT THE INSTRUMENT COULD HAVE BEEN MODIFIED BY AN EXTERNAL CONTRACTOR NOT QUALIFIED BY MEDTRONIC. THEN, CONSIDERING THE CONDITIONS WHEN THE EVENT OCCURED, WE THINK THAT THE TUBE HAS PROBABLY BROKE DURING SURGERY AFTER HAVING BEEN WEAKENED DURING PREVIOUS USE OR SHOCKS (STERILIZATION / DECONTAMINATION / DISSEMBLING WITHOUT FOLLOWING IFU ETC.). FOR THESE REASONS, THE DEVICE HAD BEEN PARTIALLY INEFFECTIVE AND THE REMOVAL, WITHOUT OPENING THE JAWS WITH THE HELP OF ANOTHER INSTRUMENT, HAS PROBABLY CAUSE THE REPORTED INJURIES. THE ORIGIN OF THE BREAKAGE IS CONSIDERED TO BE DUE TO A LACK OF CARE IN THE USE OF THE DEVICE, THAT IT HAS BEEN MODIFIED BY A NOT QUALIFIED EXTERNAL CONTRACTOR, AND THAT THE INJURIES COULD HAVE BEEN PREVENTED IF THE REMOVAL OF THE INSTRUMENT HAS BEEN DONE WITH CARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE JAWS OF THE FORCEPS USED WITH THIS HANDLE LEFT A PERFORATION THE SIZE OF THE JAWS ON THE PROXIMAL INTESTINE, WHICH NEEDED STITCHING. ACCORDING TO THE REPORT, THERE IS NO POSTOP CONSEQUENCE FOR THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND THE PRODUCT WAS ANALYZED. THE INTERVENTION WAS A GASTRIC PREPARATION FOR AN OESOPHAGECTOMY WITH THE MAKING OF A JEJUNOSTOMY. THE STOMACH BEING THICK, THE FORCEPS ONLY PROVOKED MINIMAL LESIONS ON THE GASTRIC SEROUS MEMBRANE. AT THE END OF THE INTERVENTION, WHILE THE USE WAS NORMAL, THE JAWS OF THE FORCEPS LEFT A PERFORATION THE SIZE OF THE JAWS AT THE PROXIMAL SMALL INTESTINE WITH ANOTHER WOUND RIGHT NEXT TO IT WITH THE SAME FORCEPS. THE SURGEON MADE A SUTURE UNDER COELIOSCOPY OF THE PERFORATION WITHOUT POSTOP CLINICAL CONSEQUENCE FOR THE PATIENT. (HOSPITAL REPORT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668482 HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM] LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ XOMED MICROFRANCE MFG CEV102910R 120901

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention