BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8812611 · Received July 22, 2019

    Report

    Report Number
    3005075853-2019-20606
    Event Type
    Injury
    Date Received
    July 22, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). POTENTIAL LOT NUMBERS SUPPLIED TO THE CUSTOMER MENTIONED WITHIN THE JOURNAL ARTICLE BETWEEN 2009 AND 2012: LOT # F4R401. MANUFACTURE DATE OF 12/22/2009. EXPIRATION DATE OF 11/30/2014. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE LOT. LOT # G4TA37. MANUFACTURE DATE OF 06/18/2010. EXPIRATION DATE OF 05/31/2015. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE LOT. LOT # G4UD11. MANUFACTURE DATE OF 11/29/2010. EXPIRATION DATE OF 10/31/2015. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE LOT. LOT # G4UG8F. MANUFACTURE DATE OF 12/15/2010. EXPIRATION DATE OF 11/30/2015. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE LOT. LOT # J4AK0U. MANUFACTURE DATE OF 04/23/2012. EXPIRATION DATE OF 03/31/2017. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE LOT. LOT # J4CE7Y. MANUFACTURE DATE OF 09/29/2012. EXPIRATION DATE OF 08/31/2017. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2012. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: MASSIVE INTRA-ABDOMINAL HAEMORRHAGE FOLLOWING STAPLED HAEMORRHOIDOPEXY AUTHOR: E. A. JOYCE, D. O. KAVANAGH, P. R. O¿CONNELL, J. M. P. HYLAND. CITATION: INT J COLORECTAL DIS (2012) 27:679¿680 / DOI 10.1007/S00384-011-1266-9. THE PURPOSE OF THIS CASE REPORT WAS TO DISCUSS THE OUTCOME OF MASSIVE INTRA-ABDOMINAL HAEMORRHAGE FOLLOWING STAPLED HAEMORRHOIDOPEXY. THIS WAS CONCERNING A (B)(6)-YEAR-OLD HEALTHY FEMALE WITH A 2-YEAR HISTORY OF INTERMITTENT SIGNIFICANT BLEEDING PER RECTUM. EXAMINATION REVEALED CIRCUMFERENTIAL THIRD-DEGREE HAEMORRHOIDS AND FOLLOWING AN OTHERWISE UNREMARKABLE LEFT-SIDED COLONOSCOPY, SHE WAS ADMITTED FOR AN ELECTIVE DAY CASE STAPLED HAEMORRHOIDOPEXY. A 33-MM PROXIMATE PPH-03 HAEMORRHOIDAL CIRCULAR STAPLER WAS INTRODUCED TRANSANALLY AND FOLLOWING APPOSITION OF THE MUCOSAL PURSESTRING SUTURE ON THE ANVIL, THE DEVICE WAS FIRED. FOUR HOURS POST-OPERATIVELY, SHE HAD EXTENSIVE ECCHYMOSES OF THE PERINEUM AND RETURNED TO THE OPERATING THEATRE WHICH REVEALED A LARGE INTRAMURAL (EXTRAMUCOSAL) HAEMATOMA CAUSING ANTERIOR BULGING OF THE POSTERIOR VAGINAL WALL, THE RECTAL MUCOSA WAS INCISED AND THIS WAS RELEASED TRANSRECTALLY. THREE HOURS LATER, PATIENT ACUTELY DETERIORATED, HER ABDOMEN WAS NOW DISTENDED AND PERITONITIC. SHE UNDERWENT AN EMERGENCY EXPLORATIVE LAPAROTOMY. THIS REVEALED AN EXTENSIVE HAEMOPERITONEUM WITH APPROXIMATELY 3.5 L OF FRESH AND CLOTTED BLOOD WITHIN THE ABDOMINAL CAVITY. THERE WAS EXTENSIVE HAEMATOMA WITHIN THE MESORECTUM AND MESOCOLON. A SMALL DEFECT WAS OBSERVED IN THE ANTERIOR RECTAL WALL AT THE SITE OF THE PREVIOUS TRANSRECTAL EVACUATION OF THE HAEMATOMA. THIS WAS REPAIRED WITH 2/0 VICRYL. SHE REMAINED HAEMODYNAMICALLY STABLE THEREAFTER HAVING RECEIVED 12 U OF RED CELLS AND OTHER BLOOD PRODUCTS. THIS REPORT IS A CASE OF EXTENSIVE HAEMOPERITONEUM FOLLOWING STAPLED HAEMORRHOIDOPEXY WITH NO EVIDENCE OF BLOOD LOSS PER RECTUM DESPITE THE POSSIBLE ORIGIN OF THE BLEED BEING A SMALL VESSEL IN THE MUSCULARIS PROPRIA OF THE RECTAL WALL. WHILE EXTRA-LUMINAL RECTAL BLEEDING POST-STAPLED HAEMORRHOIDOPEXY IS RARE IN COMPARISON TO VISIBLE INTRA-LUMINAL BLEEDING, IT IS IMPERATIVE THAT CLINICIANS ARE VIGILANT FOR THIS POTENTIALLY LIFE THREATENING COMPLICATION IN ORDER THAT IT CAN BE ADDRESSED PROMPTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604461 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention