BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8739166 · Received June 27, 2019

    Report

    Report Number
    3005075853-2019-20096
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    January 1, 2014
    Report Date
    May 30, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2014. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: ROLE OF 0.4 % GLYCERYL TRINITRATE OINTMENT AFTER STAPLED TRANS-ANAL RECTAL RESECTION FOR OBSTRUCTED DEFECATION SYNDROME: A PROSPECTIVE, RANDOMIZED TRIAL. AUTHORS: DOMENICO IZZO, ANTONIO BRILLANTINO, FRANCESCA IACOBELLIS, PAOLO FALCO, ADOLFO RENZI, ROBERTO REA. CITATION: INT J COLORECTAL DIS (2014); 29:105¿110. DOI: 10.1007/S00384-013-1758-X. THIS STUDY WAS DESIGNED TO EVALUATE THE INCIDENCE OF ANAL SPAM AND FISSURE AFTER STAPLED TRANS-ANAL RECTAL RESECTION (STARR) PROCEDURE AND TO TEST THE EFFECTIVENESS OF TOPICAL GLYCERYL TRINITRATE (GTN) 0.4 % IN THE EARLY POSTOPERATIVE COURSE. IN THIS STUDY, 104 PATIENTS UNDERWENT STARR AND WERE RANDOMIZED TO RECEIVE TOPICAL 0.4 % GTN OINTMENT EVERY 12 H FOR FOUR POSTOPERATIVE WEEKS (GTN GROUP; N-56) OR TO NOT RECEIVE THE TOPICAL OINTMENT (NO GTN GROUP; N-48). OF THESE, NINE PATIENTS WERE LOST AT FOLLOW-UP AND TEN PATIENTS IN GROUP 1 INTERRUPTED TREATMENT FOR THE PRESENCE OF SEVERE HEADACHES OR LOCAL DISCOMFORT (N-1). OVERALL, 85 PATIENTS (19 MALE AND 66 FEMALE; MEAN AGE: 48±10.5) COMPLETED THE POSTOPERATIVE EVALUATION, REPRESENTING THE OBJECT OF ANALYSIS. STARR PROCEDURES WERE PERFORMED USING 2 PPH-03 KITS (ETHICON). REPORTED EARLY COMPLICATIONS IN GTN GROUP INCLUDED: MILD PERINEAL HEMATOMA (N-5), PERIANAL SEPSIS (N-1), AND BLEEDING (N-4) AND IN NO GTN GROUP: MILD PERINEAL HEMATOMA (N-4), PERIANAL SEPSIS (N-1), BLEEDING (N-3), ANAL SPASM (N-6), ANAL FISSURE (N-4). LATE COMPLICATIONS IN GTN GROUP INCLUDED: URGE TO DEFECATE(N-5) AND RETAINED STAPLES (N-3) AND IN NO GTN GROUP INCLUDED: URGE TO DEFECATE(N-5) AND RETAINED STAPLES (N-2). IN CONCLUSION, ANAL SPASM AND FISSURE MAY REPRESENT A CAUSE OF EARLY POSTOPERATIVE ANAL PAIN IN PATIENTS THAT HAVE UNDERGONE STARR PROCEDURE FOR ODS. THE USE OF TOPICAL GTN 0.4 % OINTMENT IN THE EARLY POSTOPERATIVE COURSE SEEMS TO REDUCE THE INCIDENCE OF ANAL SPASM AND FISSURE AND TO IMPROVE THE ASSOCIATED EARLY POSTOPERATIVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533035 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention