BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8808632 · Received July 19, 2019

    Report

    Report Number
    3005075853-2019-20543
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    January 1, 2017
    Report Date
    June 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2017. 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. ATTEMPTS WERE MADE TO OBTAIN THE FOLLOWING INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING NO FURTHER DETAILS ARE AVAILABLE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH) WITH LOW RECTAL ANASTOMOSIS USING A PPH 03 STAPLER: LOW RATE OF RECURRENCE AND POSTOPERATIVE COMPLICATIONS. AUTHORS: YOSHIRO IIDA, HIDEO SAITO, YOSHIHIRO TAKASHIMA, KENICHIRO SAITOU AND YOSHINORI MUNEMOTO. CITATION: INT J COLORECTAL DIS (2017) 32:1687¿1692; DOI 10.1007/S00384-017-2908-3. THIS STUDY AIMED TO EVALUATE PPH WITH LOW RECTAL ANASTOMOSIS (PPH-LA) IN COMPARISON WITH THE ORIGINAL PPH AND MMH. BETWEEN JANUARY 2000 TO AUGUST 2015, A TOTAL OF 1315 PATIENTS WITH HEMORRHOIDS WERE INCLUDED IN THE STUDY. MMH WAS CONDUCTED IN 322 PATIENTS (MEAN AGE 55 ± 15, MALE N=186, FEMALE N=136), ORIGINAL PPH USING A PPH 01 STAPLER (PPH01) IN 63 PATIENTS (MEAN AGE 55 ± 14, MALE N=40, FEMALE N=23), PPH-LA USING 01 STAPLER (PPH-LA01) IN 236 PATIENTS (MEAN AGE 54 ± 14, MALE N= 162, FEMALE N=74), 03 STAPLER (PPH-LA03) IN 649 PATIENTS (MEAN AGE 55±16, MALE N=413, FEMALE N=236), AND SCLEROTHERAPY (SCL) IN 45 PATIENTS (MEAN AGE 55 ± 16, MALE N=29, FEMALE N=16). FOR PPH-LA01 AND -LA03, PURSE-STRING SUTURES WERE APPLIED AT 2.5 CM FROM THE ANORECTAL JUNCTION, WHILE FOR PPH01, THEY WERE APPLIED AT 4 CM FROM THE DENTINATE LINE. FOR PPH-LA01 AND -LA03, THE DISTANCE FROM THE ANASTOMOTIC LINE TO THE ANAL VERGE WAS 33 MM. TO PREVENT RECTOVAGINAL FISTULA, WE USED A COLPOSCOPE TO CHECK WHETHER THE VAGINAL WALL HAD BEEN PUNCTURED BY THE STAPLER. COMPLICATIONS INCLUDED MASSIVE POST-OPERATIVE BLEEDING OF 4.8% IN PPH01, 2.1% IN PPH-LA01 AND 0.5% IN PPH-LA03; POSTOPERATIVE STENOSIS OF 1.3% IN PPH-LA01 AND 1.4% IN PPH-LA03 AND CHRONIC PAIN OF 0.4% IN PPH-LA01 AND 0.2% IN PPH-LA03. ONE PATIENT WHO COMPLAINED OF CHRONIC PAIN AFTER PPH-LA01 UNDERWENT AN ELECTIVE PROCEDURE THAT INVOLVED TRANSANAL EXCISION OF THE SUTURE LINE AND RECONSTRUCTION OF THE ANASTOMOSIS USING HAND-SEWN SUTURES, AND THEN BECAME FREE OF PAIN. IN CONCLUSION, PPH-LA03 IS A SUPERIOR PROCEDURE FOR HEMORRHOIDS, HAVING LESS POSTOPERATIVE PAIN AND A LOW RATE OF RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602083 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention