BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHAMAXX

    MDR report key: 7790344 · Received August 15, 2018

    Report

    Report Number
    7790344
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 13, 2018
    Manufacturer
    MAQUET INC.
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) Y/O FEMALE WAS UNDERGOING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE TO EVALUATE POSSIBLE BOWEL OBSTRUCTION / ILEUS FOLLOWING SURGERY ON (B)(6) 2018 (ROBOTIC RIGHT HEMICOLECTOMY FOR ASCENDING COLON ADENOCARCINOMA). DURING THE LAPAROSCOPY ON (B)(6) 2018, THE PHYSICIAN ASKED THE TABLE POSITION BE ALTERED FROM A REVERSE TRENDELENBURG POSITION TO A TRENDELENBURG POSITION. THE HYDRAULICS OF THE TABLE JARRED DURING THE POSITION CHANGE CAUSING A SUDDEN DROPPING OF THE TABLE. THE PHYSICIAN HAD AN INSTRUMENT GRASPING THE BOWEL DURING THIS EVENT, AND IT LED TO TWO ENTEROTOMIES OF THE BOWEL. THE PT WAS SECURED AND ASSESSED, AND THEN TRANSFERRED TO ANOTHER OPERATING TABLE. THE CASE WAS RESUMED WITH THE DECISION TO CONVERT TO AN OPEN LAPAROTOMY. ONE ENTEROTOMY WAS REPAIRED AND THE OTHER AREA WAS RESECTED. THE PT WAS THEN RECOVERED AND RETURNED TO HER PRE-OPERATIVE BED. AFTER THE VENDOR ANALYSIS, THE TABLE WAS DECOMMISSIONED AND IS BEING REPLACED. THIS MEDWATCH REPORT IS BEING FILED TODAY, 08/13/2018. FULL DISCLOSURE WAS MADE TO THE HUSBAND AND TO THE PT BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628947 ALPHAMAXX OPERATING ROOM TABLE FQO MAQUET INC. 113302F2

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| O