BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN

    MDR report key: 22790788 · Received August 13, 2025

    Report

    Report Number
    3010216206-2025-00020
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    June 8, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FWZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: MODEL # AND D4: CATALOGUE #: THE POTENTIAL NUMBERS ARE O-YFES OR O-YFASI. D4: UNIQUE IDENTIFIER (UDI) #: THE POTENTIAL UDIS ARE (B)(4). F10/H6: HEALTH EFFECT - CLINICAL CODES: E1644: CONDITION IN WHICH A CLOSED MUSCLE COMPARTMENT'S PRESSURE INCREASES TO SUCH AN EXTENT THAT THE CIRCULATION IS DIMINISHED, E.G. DUE TO DECREASE IN A COMPARTMENT VOLUME OR AN INCREASE IN THE CONTENTS OF A COMPARTMENT, OR BOTH. H11: THE DEVICE WAS EVALUATED ON-SITE BY A BAXTER QUALIFIED TECHNICIAN. THE DEVICE WAS VISIBLY INSPECTED AND FOUND THE BOOTS WITH ORIGINAL PARTS AND ORIGINAL FOAM WITHOUT PRESSURE IN THE CALF AREA. THE INSTRUCTIONS FOR USE (IFU) STATE TO INSPECT THE PRODUCT FOR ANY VISIBLE DAMAGE AND NOT TO USE THE DEVICE IF THE PRODUCT SHOWS VISIBLE DAMAGE. ADDITIONALLY, THE IFU STATES TO ACCESS THE PATIENT FOR ANY PRE-EXISTING CONDITIONS THAT MIGHT CONTRAINDICATE THE USE OF LEG POSITIONING DEVICES. IN THE LITHOTOMY POSITION, THE PATIENT BEGINS SUPINE, AND THE LEGS ARE LIFTED INTO LOW-PADDED STIRRUPS. THE IFU INSTRUCTS THE USER THAT POSITIONING SHOULD BE PERFORMED BY TWO STAFF MEMBERS. THE IFU OUTLINES THE PROPER PATIENT POSITIONING GUIDELINES INCLUDING WHEN USING LOW LITHOTOMY, "TAKE CARE NOT TO HYPEREXTEND THE LEG WHILE ACHIEVING DESIRED ABDUCTION, AND WHEN USING MEDIUM OR HIGH LITHOTOMY, USE MINIMAL INITIAL LEG FLEXION AND ABDUCTION AS BOTH WILL INCREASE AS LEGS ARE RAISED." THE IFU ALSO RECOMMENDS THAT "WHENEVER PRACTICAL, A PATIENT SHOULD BE PLACED IN THE STIRRUPS PRIOR TO ANESTHESIA", AN ALERT PATIENT CAN COMMUNICATE NORMAL RANGE OF MOTION LIMITATIONS AND TO SOME EXTENT, THE PATIENT'S OPPOSING MUSCLES WILL GUARD AGAINST ABNORMAL JOINT PLACEMENT AND STRETCHING. SURGICAL POSITIONING INJURY IS A SIDE EFFECT/COMPLICATION IN AN INTRAOPERATIVE SETTING, WHICH IS COMMONLY ATTRIBUTED TO IMPROPER PATIENT POSITIONING AND PROLONGED SURGERY TIMES. DURING EXTENDED SURGICAL PROCEDURES, IT IS COMMON PRACTICE AND A PREVENTIVE MEASURE TO CHECK THE PATIENT'S POSITION, ENSURING THAT THERE IS NO UNDUE PRESSURE OR OBSTRUCTION OF VASCULAR SUPPLY TO ANY BODY PART, WHICH INCLUDES ALLOWING THE PATIENT'S BODY TO REST FROM AN EXTENDED, AWKWARD POSITION. THE POTENTIAL HAZARDS TO THE PATIENT IN THE LITHOTOMY POSITION ARE SKIN BREAKDOWN, NERVE DAMAGE, MUSCULOSKELETAL INJURY (IMPROPER RAISING AND LOWERING OF THE LEGS), AND CIRCULATORY COMPROMISE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, A PATIENT WAS PUT IN YELLOWFIN STIRRUPS FOR POSITIONING DURING A PROCEDURE, AND FOLLOWING THE PROCEDURE, THE PATIENT PRESENTED WITH ¿COMPARTMENT SYNDROME.¿ THE PATIENT UNDERWENT A 9 HOUR ROBOTIC-ASSISTED ENDOMETRIOSIS SURGERY WHEREIN THE PATIENT WAS POSITIONED IN LITHOTOMY POSITION. THE FOLLOWING DAY, THE PATIENT PRESENTED WITH PAIN THAT IS DIFFICULT TO CONTROL IN THE RIGHT LOWER LIMB, MYOSITIS WITH EDEMA IN THE ¿SOLEUS AND GASTROCNEMIUS¿, ASSOCIATED WITH SIGNS OF DENERVATION. A VENOUS DOPPLER WAS PERFORMED, WITH NO SIGNS OF DEEP VEIN THROMBOSIS. ADDITIONALLY, THE CREATINE PHOSPHOKINASE (CPK) WAS ELEVATED, INDICATING COMPARTMENT SYNDROME INDICATING A FASCIOTOMY. THE ATTENDING PHYSICIAN DID NOT AGREE WITH THE SURGICAL INTERVENTION AND DISCHARGED THE PATIENT HOME THE FOLLOWING DAY DESPITE PERSISTENT PAIN, DIFFICULTY IN WALKING, AND PARESTHESIA IN THE RIGHT FOOT. THE USE OF A WALKER WAS ADVISED IF NECESSARY AND HOME FOLLOW-UP WITH A PHYSIOTHERAPIST FOR MOTOR REHABILITATION. THE DOCTOR REPORTED THAT THE PATIENT REMAINED IN PAIN, EVEN WITH THE HOME USE OF PREGABALIN AND TORAGESIC. FURTHERMORE, MOTOR PHYSIOTHERAPY SESSIONS WERE WARRANTED AND AN MAGNETIC RESONANCE IMAGING WERE PERFORMED WHICH IDENTIFIED MYOSITIS. CURRENTLY, THE PATIENT HAS PAIN THAT IS DIFFICULT TO CONTROL AND HYPERESTHESIA IN THE PLANTAR REGION OF THE RIGHT FOOT. THE INSTRUCTIONS FOR USE (IFU) STATE TO INSPECT THE PRODUCT FOR ANY VISIBLE DAMAGE AND NOT TO USE THE DEVICE IF THE PRODUCT SHOWS VISIBLE DAMAGE. ADDITIONALLY, THE IFU STATES TO ACCESS THE PATIENT FOR ANY PRE-EXISTING CONDITIONS THAT MIGHT CONTRAINDICATE THE USE OF LEG POSITIONING DEVICES. IN THE LITHOTOMY POSITION, THE PATIENT BEGINS SUPINE, AND THE LEGS ARE LIFTED INTO LOW-PADDED STIRRUPS. THE IFU INSTRUCTS THE USER THAT POSITIONING SHOULD BE PERFORMED BY TWO STAFF MEMBERS. THE IFU OUTLINES THE PROPER PATIENT POSITIONING GUIDELINES INCLUDING WHEN USING LOW LITHOTOMY, "TAKE CARE NOT TO HYPEREXTEND THE LEG WHILE ACHIEVING DESIRED ABDUCTION, AND WHEN USING MEDIUM OR HIGH LITHOTOMY, USE MINIMAL INITIAL LEG FLEXION AND ABDUCTION AS BOTH WILL INCREASE AS LEGS ARE RAISED." THE IFU ALSO RECOMMENDS THAT "WHENEVER PRACTICAL, A PATIENT SHOULD BE PLACED IN THE STIRRUPS PRIOR TO ANESTHESIA", AN ALERT PATIENT CAN COMMUNICATE NORMAL RANGE OF MOTION LIMITATIONS AND TO SOME EXTENT, THE PATIENT'S OPPOSING MUSCLES WILL GUARD AGAINST ABNORMAL JOINT PLACEMENT AND STRETCHING. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763010 ALLEN OPERATING ROOM ACCESSORIES TABLE TRAY FWZ BAXTER HEALTHCARE CORPORATION ASKU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Life Threatening DIPYRONE| LIDOCAINE| MORPHINE| ONDASETRONA| PANTOPRAZOLE| PROPOFOL| REMIFENTANIL| ROPIVACAINE| SCOPOLAMINE| SUGAMMADEX| TRANSAMIN