BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8722689 · Received June 21, 2019

    Report

    Report Number
    3005075853-2019-19932
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: PROSPECTIVE MULTICENTRE CLINICAL TRIAL OF STAPLED TRANSANAL RECTAL RESECTION FOR OBSTRUCTIVE DEFAECATION SYNDROME. AUTHOR(S): A. ARROYO, F. X. GONZALEZ-ARGENTE, M. GARCIA-DOMINGO, E. ESPIN-BASANY, F. DE-LA-PORTILLA, F. PEREZ-VICENTE AND R. CALPENA. CITATION: BRITISH JOURNAL OF SURGERY 2008; 95: 1521¿1527 / DOI: 10.1002/BJS.6328. THE PURPOSE OF THIS PROSPECTIVE MULTICENTER STUDY WAS TO ASSESS THE SAFETY AND EFFECTIVENESS OF STAPLED TRANSANAL RECTAL RESECTION (STARR) FOR TREATMENT OF OBSTRUCTIVE DEFAECATION SYNDROME (ODS). BETWEEN FEB 2001 AND JUN 2006, A TOTAL OF 104 PATIENTS [MEAN AGE 58.3 YEARS (RANGE 32 TO 76 YEARS)] DIAGNOSED WITH OBSTRUCTIVE DEFAECATION SYNDROME (ODS) WERE TREATED WITH STARR. A TRANSPARENT ANOSCOPE, PART OF A PPH KIT FOR STAPLED HAEMORRHOIDECTOMY PPH33 (ETHICON) WAS INTRODUCED INTO THE ANUS AND FIXED TO THE SKIN WITH SILK SUTURES. SEVERAL SEPARATED HALF-SIZE (180°) PURSE-STRING SUTURES, SURGILENE, INCLUDING ANTERIOR MUCOSA, SUBMUCOSA AND RECTAL WALL, WERE INSERTED FROM 1¿2 CM ABOVE THE HAEMORRHOIDAL APEX TO THE TOP OF THE RECTOCELE. THE STAPLER WAS INSERTED IN THE ANAL CANAL AND THEN FIRED, TAKING CARE TO INCLUDE THE FULL RECTAL WALL ANTERIORLY. A PPH33-01 STAPLER WAS USED BETWEEN FEB 2001 AND JAN 2004, AND THE PPH33-03 WAS EMPLOYED THEREAFTER. POSTOPERATIVE COMPLICATIONS INCLUDED HAEMORRHAGE AT THE STAPLE LINE [N=55 (N=28 USE PPH33-01, N=27 USE PPH33-03)] WHICH WAS CONTROLLED DURING SURGERY WITH HAEMOSTATIC SUTURES IN ALL PATIENTS; AND THREE PATIENTS REQUIRED SURGICAL REVISION IN THE FIRST 48 HOURS OWING TO PERSISTENT BLEEDING; PAIN DURING FIRST WEEK AFTER SURGERY (N=104); FAECAL INCONTINENCE AT 1 MONTH (N=23) WHICH WAS REVERSED SPONTANEOUSLY WITHOUT TREATMENT WITHIN 6 MONTHS; INCONTINENCE AT 6 MONTHS (N=9); MINOR RESIDUAL INCONTINENCE BY 1 YEAR (N=9); FAILURE AT 1 YEARS / ODS HAD RECURRED OR PERSISTED RADIOLOGICALLY AND/OR CLINICALLY (N=11); PERSISTENT ANAL PAIN (N=1) WHICH HAD TO HAVE STAPLES CLOSE TO THE DENTATE LINE REMOVED; URGE TO DEFAECATE AT 1 MONTH (N=28) WHICH DISAPPEARED AFTER 3 MONTHS OR 6 MONTHS; URGE TO DEFAECATE AT 3 MONTHS (N=15); URGE TO DEFAECATE AT 6 MONTH (N=7); URGE TO DEFAECATE AT 12 MONTH (N=6); ANASTOMOTIC STENOSIS (N=1) WHICH IMPROVED WITH DIGITAL DILATATION AND FOUND ASYMPTOMATIC AT 1-YEAR FOLLOW-UP; TENESMUS OR DISCOMFORT ON DEFAECATION AT 1 WEEK (N=15); POSTOPERATIVE BLEEDING AT 1 MONTH (N=104) STARR IS A SHORT, SAFE AND EFFECTIVE PROCEDURE. ADHERENCE TO STRICT SELECTION CRITERIA IS THE KEY TO OBTAINING THE BEST RESULTS IN THE TREATMENT OF ODS, AND THE INDISCRIMINATE USE OF THIS TECHNIQUE IS TO BE AVOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515446 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1