BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN

    MDR report key: 22781675 · Received August 12, 2025

    Report

    Report Number
    3010216206-2025-00018
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    June 26, 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). H11: THE DEVICE WAS EVALUATED ON-SITE BY A BAXTER QUALIFIED TECHNICIAN. THE DEVICE WAS VISIBLY INSPECTED AND FOUND NON-ORIGINAL PARTS AND NON-ORIGINAL FOAM ON THE STIRRUPS. 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 WAS UNDERGOING AN ELECTIVE PROCEDURE FOR THE TREATMENT AND EXCISION OF DEEP ENDOMETRIAL LESIONS WHEREIN THE PATIENT WAS POSITIONED IN LITHOTOMY, WITH PLACEMENT OF LEGS BY THE UROLOGY TEAM INTO THE STIRRUPS. AFTER THE PROCEDURE BEGAN, THE GYNECOLOGICAL SURGEON NEEDED TO ADJUST ONE OF THE PATIENT¿S LEGS, AND ¿THERE WAS DESTABILIZATION OF THE EQUIPMENT, RESULTING IN SUDDEN MOVEMENT OF THE LEFT LOWER LIMB.¿ THE LEG WAS PROMPTLY SUPPORTED BY THE SURGEON. NO VISIBLE LESIONS WERE OBSERVED AT THIS TIME. THE SURGICAL TEAM CHANGED THEIR STERILE GOWNS AND THE PROCEDURE CONTINUED FOR 6 HOURS AND 35 MINUTES. REPORTEDLY, THE PATIENT WAS KEPT IN THE SAME POSITION, WITHOUT REASSESSMENT OF THE AFFECTED LIMB. AT THE END OF THE SURGERY, WHILE STILL IN THE ROOM, THE PATIENT REPORTED PAIN IN THEIR LEFT CALF. DURING ANESTHETIC RECOVERY, THE PAIN PERSISTED, AND WAS REASSESSED BY THE ANESTHESIOLOGIST, WHO OBSERVED SWELLING TO THE LEFT LOWER LIMB, ¿ASSOCIATED WITH DIFFICULTY IN MOBILIZATION, PARESTHESIA AND LOSS OF MUSCLE STRENGTH.¿ THE VASCULAR SURGERY TEAM WAS CONSULTED AND DETERMINED EMERGENT FASCIOTOMY INTERVENTION WAS REQUIRED FOR SUSPECTED COMPARTMENT SYNDROME. POST PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), WHERE THE PATIENT DEVELOPED RHABDOMYOLYSIS, ¿PAIN THAT WAS DIFFICULT TO CONTROL (WHICH REQUIRED MORPHINE IN A PCA PUMP), CONTINUOUS INFUSION OF KETAMINE, AND OTHER ¿RESCUE¿ ANALGESICS. EIGHT DAYS POST OPERATIVE (POST-OP) THE PATIENT UNDERWENT A ¿DEBRIDEMENT OF THE WOUND AT THE FASCIOTOMY SITE.¿ TWO DAYS AFTER THAT THE PATIENT UNDERWENT A SURGICAL PLACEMENT OF A VACUUM DRESSING. FIVE DAYS POST-OP FROM THE VACUUM DRESSING, THE PATIENT REMAINED IN ICU RECEIVING ANALGESIA. SEVEN DAYS LATER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND POTENTIALLY RETURNING FOR A ¿REAPPROACH FASCIOTOMY.¿ 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364804 ALLEN OPERATING ROOM ACCESSORIES TABLE TRAY FWZ BAXTER HEALTHCARE CORPORATION ASKU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention 0.9% SALINE SOLUTION| BUPIVACAINE WITH GLUCOSE| CEFAZOLIN| CLONIDINE| DEXAMETHASONE| DIPYRONE| FENTANYL| KETAMINE| KETOROLAC| LACTATED RINGER'S| MIDAZOLAM| MORPHINE| ONDANSETRON| PROPOFOL| REMIFENTANIL| ROCURONIUM| SUGAMMADEX| TRANEXAMIC ACID