BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8547457 · Received April 24, 2019

    Report

    Report Number
    3005075853-2019-18416
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 23, 2019
    Report Date
    April 5, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 02/22/2023. MEDICAL RECORDS RECEIVED. PLEASE SEE ATTACHED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 02/22/2023. MEDICAL RECORDS RECEIVED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 02/22/2023 MEDICAL RECORDS RECEIVED. PLEASE SEE ATTACHED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 02/22/2023. MEDICAL RECORDS RECEIVED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 02/22/2023. MEDICAL RECORDS RECEIVED. PLEASE SEE ATTACHED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION: CAN YOU PLEASE PROVIDE FURTHER DETAIL OF THIS EVENT - "FAILURE TO SUTURE ONE THIRD OF THE CIRCUMFERENCE OF THE RECTUM."? WHAT DEGREE OF HEMORRHOIDS DID THE PATIENT HAVE? WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE WAS FULLY FIRED? WHERE WITHIN THE GAP SETTING SCALE WAS THE ORANGE INDICATOR PRIOR TO FIRING? DID THE DEVICE CUT? IF THE DEVICE CUT WAS THE CUT LINE FULLY CIRCUMFERENTIAL AROUND THE TARGET TISSUE? WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES (B-FORMATION, IRREGULAR, STRAIGHT LEGS)? HOW WAS IT CONFIRMED THAT THE ANVIL WAS FREE FROM THE TISSUE PRIOR TO REMOVING? AFTER FIRING WAS THE ADJUSTING KNOB TURNED ½ TO ¾ REVOLUTIONS? WAS THE DEVICE ROTATED 90 DEGREES IN BOTH DIRECTIONS TO ENSURE THE ANVIL WAS FREE FROM THE TISSUE? WHO FIRED THE DEVICE? WHO REMOVED THE DEVICE? WAS THE SAFETY RESET PRIOR TO REMOVAL? WHAT WAS THE USERS EXPERIENCE WITH THE DEVICE? HOW WAS THE PROCEDURE COMPLETED? WAS THERE ANY CHANGE IN THE PROCEDURE OR PATIENT CARE AS A RESULT OF THE EVENT? TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR PROLAPSE AND HEMORRHOIDS, THERE WAS A FAILURE TO SUTURE ONE THIRD OF THE CIRCUMFERENCE OF THE RECTUM. PATIENT CONSEQUENCE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340664 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PPH03 R9421F 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Unknown