BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8809904 · Received July 20, 2019

    Report

    Report Number
    3005075853-2019-20578
    Event Type
    Injury
    Date Received
    July 20, 2019
    Date of Event
    January 1, 2008
    Report Date
    June 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2008. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: RANDOMIZED CLINICAL TRIAL OF STAPLED HAEMORRHOIDOPEXY PERFORMED UNDER LOCAL PERIANAL BLOCK VERSUS GENERAL ANAESTHESIA. AUTHORS: R. GERJY, A. LINDHOFF-LARSON, R. SJODAHL AND P.-O. NYSTROM. CITATION: BRITISH JOURNAL OF SURGERY (2008); 95: 1344¿1351. DOI: 10.1002/BJS.6379. THE AIM OF THIS STUDY WAS TO ASSESS THE FEASIBILITY OF PERFORMING STAPLED HAEMORRHOIDOPEXY UNDER LOCAL ANAESTHESIA. THIS OPEN, PROSPECTIVE, SINGLE-CENTER RANDOMIZED CONTROLLED TRIAL INVOLVES 51 PATIENTS WHICH WERE RANDOMIZED TO EITHER LOCAL OR GENERAL ANESTHESIA BETWEEN APRIL 2004 AND NOVEMBER 2005. THE GENERAL ANESTHESIA (GA) GROUP CONSISTS OF 25 PATIENTS (11 MALE AND 14 FEMALE; AGE RANGE: 29 TO 75 YEARS) AND THE LOCAL ANESTHESIA (LA) GROUP HAD 26 PATIENTS (13 MALE AND 13 FEMALE; AGE RANGE: 32 TO 81 YEARS). A PPH03 KIT (ETHICON) WAS USED IN ALL OPERATIONS. REPORTED COMPLICATIONS IN LA GROUP INCLUDED POSTOPERATIVE BLEEDING (N-1) IN WHICH THE PATIENT WAS ADMITTED OVERNIGHT FOR A REOPERATION, EXCESSIVE PAIN (N-1) IN WHICH THE PATIENT STAYED OVERNIGHT, POSTOPERATIVE PAIN (N-?), ACUTE ANAL FISSURE (N-1) RESULTING TO EXCESSIVE POSTOPERATIVE PAIN, ANAL SPASM (N-1) RESULTING TO EXCESSIVE POSTOPERATIVE PAIN WHICH WAS RESOLVED WITH DILTIAZEM OINTMENT, AND MILD FECAL URGENCY (N-3). IN GA GROUP, REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE PAIN (N-?), EXCESSIVE POSTOPERATIVE PAIN (N-1) WHICH RESOLVED SPONTANEOUSLY, AND MILD FECAL URGENCY (N-2). IN CONCLUSION, PERIANAL LOCAL BLOCK IS EASY TO APPLY WITH A HIGH DEGREE OF ACCEPTABILITY AMONG PATIENTS. POSTOPERATIVE PAIN, RESTORATION OF ANATOMY AND SYMPTOM RESOLUTION WERE SIMILAR TO THAT OF STAPLED HAEMORRHOIDOPEXY PERFORMED UNDER GENERAL ANAESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603586 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R