BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSYN

    MDR report key: 7293421 · Received February 23, 2018

    Report

    Report Number
    9612501-2018-00246
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Report Date
    February 23, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ENTEROTOMY VETERINARY PROCEDURE, THE DEVICE FAILED. HE PRESENTED TO A SURGEON WITH INAPPETENCE, ONE EPISODE OF BILIOUS VOMITING AND LETHARGY. HE WAS QAR, MUCUS MEMBRANES PINK BUT TACKY AND A SAUSAGE SIZED LUMP IN THE CAUDAL ABDOMEN WHICH HE REACTED TO. THE DECISION WAS MADE TO ADMIT HIM FOR BLOODS, FLUIDS, ABDOMINAL SCAN AND X-RAY. ON ULTRASOUND THERE WAS A LARGE HOMOGENOUS MASS IN THE CAUDAL ABDOMEN AND DILATED LOOPS OF SMALL INTESTINES, DIFFERENTIALS BEING TUMOUR OR FOREIGN BODY. ON X-RAY THERE WERE MASSIVELY DILATED LOOPS OF SMALL INTESTINE, SO WE WERE UNABLE TO VISUALISE ANYTHING ELSE IN THE ABDOMEN. CONSENT WAS GAINED FROM THE OWNER TO UNDERGO A EXPLORATORY LAPAROTOMY. THERE WERE MASSIVELY DILATED LOOPS OF INTESTINE WITH INJECTED BLOOD VESSELS BUT THE GUT WAS STILL A PINKY/RED COLOUR. THERE WERE 2 AREAS ABOUT 10CM APART FROM EACH OTHER IN THE JEJUNUM WHERE TWO HALVES OF A TENNIS BALL WERE STUCK, THEY HAD DILATED THE INTESTINE BUT HAD NOT REACHED THE STAGE OF PERFORATION. TWO ENTEROTOMY INCISIONS WERE MADE AND THE FOREIGN BODIES WERE REMOVED. THE INTESTINE WAS SUTURED INTERRUPTED STITCHES WITH ANOTHER VET SCRUBBED IN ACTING AS BOWEL CLAMPS. THE TWO SUTURE LINES WERE CHECKED BY MULTIPLE VETS AND INGESTA WAS MILKED ALONG TO THE INCISION SITE AND LEAK TESTED AND THERE WAS NO LEAKAGE OBSERVED. 3 LITRES OF SALINE WERE USED TO FLUSH THE ABDOMEN AND CLOSED WITH SUTURE SIMPLE CONTINUOUS. AUGMENTIN WAS ADMINISTERED INTRAOPERATIVELY AND POST-OPERATIVELY ALONG WITH METRONIDAZOLE AND REFERRAL TO VETS NOW OVERNIGHT WAS DISCUSSED WITH THE OWNER BUT DECLINED. THE DOG VOMITED MULTIPLE TIMES AND ON SCANNING OF THE ABDOMEN THERE WAS SOME FREE FLUID BUT IT WAS CLEAR SEROSANGUINOUS AND CYTOLOGY WAS INCONCLUSIVE. THE DOG HAD A CONSISTENTLY HIGH TEMPERATURE AND VOMITED TWICE A DARK GREEN FLUID AND HAD DIARRHEA. THE SURGEON MADE THE DECISION TO RE-OPEN THE DOG. EX-LAP INITIALLY REVEALED FECAL CONTAMINATION OF THE ABDOMEN WITH ALOT OF FREE FLUID PRESENT AND FAECAL MATERIAL WAS LEAKING THROUGH BOTH ENTEROTOMY SITES. THE SUTURES WERE STILL IN THE GUT BUT HADN¿T ADHERED PROPERLY BUT THE BLOOD SUPPLY TO THE INTESTINE WAS FINE SO THE EDGES OF THE ENTEROTOMY SITES WERE REFRESHED AND RE-SUTURED IN A SIMPLE INTERRUPTED PATTERN. BOTH SITES HAD NO LEAKAGE POST SUTURING AND THE ABDOMEN WAS FLUSHED THOROUGHLY. CONTINUED ON AUGMENTIN AND METRONIDAZOLE ,WHEN HE WAS DISCHARGED AND THERE WAS NO DISCHARGE FROM THE WOUND WHEN RETURNED FOR A POST-OP CHECK .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136314 BIOSYN SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM DAVIS & GECK CARIBE LTD UNKNOWN - BIO

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO