BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 8726741 · Received June 24, 2019

    Report

    Report Number
    2210968-2019-83174
    Event Type
    Injury
    Date Received
    June 24, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: LANCET 2000; 356: 730¿33 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: PERSISTENT PAIN AND FAECAL URGENCY AFTER STAPLED HAEMORRHOIDECTOMY". AUTHOR(S): MARK J CHEETHAM, NEIL J M MORTENSEN, PER-OLOF NYSTROM, MICHAEL A KAMM, ROBIN K S PHILLIPS. CITATION: LANCET 2000; 356: 730¿33. THIS COMBINATION OF PILOT AND RANDOMIZED CONTROLLED TRIAL AIMED TO COMPARE DIATHERMY HAEMORRHOIDECTOMY WITH THE NEW STAPLED OPERATION IN A DAYCARE SETTING, AND TO DETERMINE THE LONG-TERM EFFICACY OF THE NEW OPERATION. A TOTAL OF 22 MALE PATIENTS UNDERWENT STAPLED HAEMORRHOIDECTOMIES. ALL OPERATIONS WERE DONE IN THE LITHOTOMY POSITION UNDER GENERAL ANAESTHESIA BY MEANS OF THE PPH01 STAPLING DEVICE (ETHICON). A 3/0 MONOCRYL PURSE-STRING SUTURE WAS USED TO SECURE THE RECTAL MUCOSA AROUND THE SHAFT OF THE STAPLING DEVICE. SHORT-TERM OUTCOME INCLUDED ONE PATIENT WHO WAS SCHEDULED AS A DAY CASE WAS ADMITTED OVERNIGHT BECAUSE OF SEVERE PAIN REQUIRING PARENTERAL OPIOIDS; AND TWO PATIENTS BLED POSTOPERATIVELY AND WERE RETURNED TO THE OPERATING THEATRE FOR SUTURE-LIGATION OF A BLEEDING POINT. AT 7 MONTHS FOLLOW-UP, A (B)(6)-YEAR-OLD MALE PATIENT EXPERIENCED SEVERE POST-DEFECATORY PAIN. SIMILAR SYMPTOM WAS REPORTED IN A (B)(6)-YEAR-OLD MALE PATIENT AT 8 MONTHS FOLLOW-UP. AT 14 MONTHS FOLLOW-UP, A (B)(6) ¿YEAR-OLD PATIENT DEVELOPED ANAL DISCOMFORT ON SITTING AND FAECAL URGENCY. AT 15 MONTHS FOLLOW-UP, A (B)(6)-YEAR-OLD MALE PATIENT DEVELOPED INCREASED STOOL FREQUENCY, URGENCY AND ANAL PAIN; AND A (B)(6)-YEAR-OLD MALE PATIENT EXPERIENCED FAECAL URGENCY AND ANAL ¿BURNING¿ SENSATION. THE CAUSE OF THIS PAIN AND URGENCY IS UNCLEAR. IMPINGEMENT OF THE STAPLE LINE ON THE SENSITIVE SQUAMOUS EPITHELIUM OF THE ANODERM WOULD BE EXPECTED TO CAUSE EARLY PAIN, BUT ON EXAMINATION OF THESE PATIENTS, THE STAPLE LINES LIE AT THE CORRECT HEIGHT WITHIN THE ANAL CANAL. ANAL DILATATION HAS BEEN SHOWN TO CAUSE INTERNAL SPHINCTER FRAGMENTATION AND FAECAL INCONTINENCE IN SOME PATIENTS, BUT ENDOANAL ULTRASONOGRAPHY SHOWED THE ANAL SPHINCTERS TO BE INTACT IN OUR PATIENTS. THE INCLUSION OF SMOOTH MUSCLE IN THE DOUGHNUT MIGHT BE REGARDED AS RELEVANT TO THE SUBSEQUENT DEVELOPMENT OF PAIN. IT WAS FOUND IN FOUR OF THE FIVE PROBLEM CASES, BUT IN ONLY ONE OF THE 11 UNAFFECTED CASES. BUT MUSCLE INCLUSION IS CLEARLY NOT AN ADEQUATE EXPLANATION (SINCE ONE AFFECTED PATIENT DID NOT HAVE IT), NOR IS IT A GUARANTEED CAUSE (SINCE ONE UNAFFECTED PATIENT HAD MUSCLE INCLUDED). THESE DATA SHOULD MAKE THE SURGEON WARY OF INCORPORATING MUSCLE INTO THE STAPLE LINE. BUT PURSE STRING PLACEMENT IS NOT ALWAYS PRECISE, PARTICULARLY WHEN HAEMORRHOIDS ARE LARGE, AND IF THE TECHNIQUE HAS AN INEVITABLE RISK OF SUCH A COMPLICATION AND IF THAT COMPLICATION REALLY IS THE EXPLANATION FOR THE PROBLEM (AT LEAST IN SOME PATIENTS), THEN THE WHOLE NATURE OF THE OPERATION MAY BE FLAWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523041 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention