BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8810019 · Received July 20, 2019

    Report

    Report Number
    2210968-2019-84515
    Event Type
    Malfunction
    Date Received
    July 20, 2019
    Report Date
    June 25, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    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: ASIAN JOURNAL OF SURGERY (2007); 30(1): 29-33. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: STAPLED HAEMORRHOIDOPEXY FOR PROLAPSED HAEMORRHOIDS: SHORT- AND LONG-TERM EXPERIENCE" AUTHORS: DAVIDE LOMANTO AND AVINASH N. KATARA CITATION: ASIAN JOURNAL OF SURGERY (2007); 30(1): 29-33. THE AIM OF THIS STUDY WAS TO REPORT LONG-TERM EXPERIENCE OF PATIENTS WITH PROLAPSED HAEMORRHOIDS TREATED WITH STAPLED HAEMORRHOIDOPEXY. BETWEEN OCTOBER 1998 AND JUNE 2005, 496 ELECTIVE PATIENTS (252 MALE AND 244 FEMALE; AGE RANGE: 21¿77 YEARS) WITH NONCOMPLICATED PROLAPSING HAEMORRHOIDS WERE TREATED WITH STAPLED HAEMORRHOIDOPEXY. A PPH01 KIT (ETHICON) THAT CONSISTED OF CIRCULAR ANAL DILATOR (CAD 33), PURSE-STRING SUTURE ANOSCOPE (PSA), SUTURE THREADER AND 33 MM HAEMORRHOIDAL CIRCULAR STAPLER WAS USED. AFTER THE DENTATE LINE WAS IDENTIFIED, USING THE PURSE-STRING ANOSCOPE, A CIRCUMFERENTIAL SUTURE, BY 2-0 PROLENE (ETHICON) WITH 24¿26MM ROUND BODY NEEDLE, WAS MADE. REPORTED COMPLICATIONS INCLUDED INTRAOPERATIVE BLEEDING FROM THE STAPLE LINE (N- 184) WHICH WAS TREATED WITH ABSORBABLE SUTURE TO STOP OOZE BLEEDING, MUCOSAL RESECTED DOUGHNUT WAS FOUND TO BE INCOMPLETE (N-8) IN WHICH THE DEFECT WAS OVERSEWN WITH 3-0 ABSORBABLE SUTURE, BREAKAGE OF THE SUTURE (N-4) AND INADVERTENT KNOTTING (N-2) IN WHICH THE PURSE-STRING SUTURE HAD TO BE REDONE, PAIN VAS SCORE MEAN OF 2.3 AT 24 HOURS AND PAIN VAS SCORE MEAN OF 1.9 AFTER 5 DAYS (N-403). EARLY COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING (N- 21), GAS INCONTINENCE (N-6) THAT RESOLVED AFTER 4 MONTHS, ANAL FISSURE (N-4) RESULTING TO PAIN WHICH WAS TREATED, STRICTURE (LESS THAN ONE FINGER) OF THE SUTURE LINE AFTER OPERATION (11) WHICH WERE TREATED BY DIGITAL DILATION WITHOUT ANAESTHESIA IN THE OUTPATIENT CLINIC, RECURRENCE OF STRICTURE (N-1) WHO REQUIRED AN ADDITIONAL FINGER DILATION AFTER 3 MONTHS. LONG-TERM COMPLICATIONS INCLUDED PAIN ON STRAINING (N-2) WHICH THE PATIENTS RECEIVED CONSERVATIVE TREATMENT, FECAL URGENCY (N-2) WHICH THE PATIENTS RECEIVED CONSERVATIVE TREATMENT, OCCASIONAL BLEEDING (N-3) WHICH THE PATIENTS RECEIVED CONSERVATIVE TREATMENT, STENOSIS (N-23) WHICH WAS TREATED WITH DIGITAL DILATION, THROMBOSIS OF EXTERNAL PILES (N-5) IN WHICH A SURGERY WAS PERFORMED, SKIN TAGS (N-18) IN WHICH A SURGERY WAS PERFORMED, AND ANAL FISSURE (N-4) IN WHICH A SURGERY WAS PERFORMED. IN CONCLUSION, SHORT- AND LONG-TERM RESULTS SHOW THAT STAPLED HAEMORRHOIDOPEXY FOR HAEMORRHOIDS IS A SAFE PROCEDURE WITH LESS PAIN AND LOWER COMPLICATION RATE COMPARED TO CONVENTIONAL HAEMORRHOIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603738 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1