BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN PAL STIRRUPS

    MDR report key: 1892863 · Received November 3, 2010

    Report

    Report Number
    1221538-2010-00007
    Event Type
    Other
    Date Received
    November 3, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAL STIRRUP WAS RECEIVED FOR EVALUATION ON (B)(6) 2010. IT WAS NOTED THAT THE STIRRUP'S PROTECTIVE CYLINDER GUARD HAD BEEN REMOVED FROM THE DEVICE. ON (B)(6) 2010, ALLEN SPOKE WITH OPERATING ROOM TECH INVOLVED INJURED IN THE INCIDENT. IT WAS LEARNED THAT THE PRODUCT WAS NOT IN USE WHEN THE INCIDENT OCCURRED. THE TECH PICKED THE STIRRUP UP FROM THE FLOOR WITH HER LEFT HAND WAS ON THE STIRRUP'S BOOT AND THE RIGHT HAND NEAR THE CYLINDER. WHEN TRANSPORTING THE STIRRUP ACROSS THE ROOM, THE HANDLE CONTACTED THE WALL OR A TABLE - ACTUATING THE STIRRUP AND CLOSING THE GAP IN THE AREA OF THE TECH'S RIGHT HAND, WHICH BECAME CAUGHT. IN AN ATTEMPT TO FREE HERSELF, THE TECH ACTUATED THE HANDLE AGAIN BUT INSTEAD OF FREEING HER HAND, IT INJURED HER THUMB. THE TECH SAID THAT THE PAL STIRRUP DID NOT HAVE THE BLACK PROTECTIVE COVER OVER THE CYLINDER AND THAT IN THE YEAR-AND-A-HALF SHE HAS WORKED AT (B)(6), NONE OF THE PAL STIRRUPS IN USE AT THE FACILITY HAD THIS GUARD IN PLACE. AN ALLEN ENGINEER EVALUATED THE PAL STIRRUP AND WITH THE EXCEPTION OPF THE MISSING GUARD THERE WERE NO OTHER SAFETY ISSUES IDENTIFIED. A REVIEW OF ALLEN'S REPAIR RECORDS DEMONSTRATED THE SUBJECT PAL STIRRUP HAD THE CYLINDER GUARD IN PLACE WHEN IT WAS PROCESSED FOR A REPAIR ON (B)(6) 2006. DURING THE SHARING OF THE INVESTIGATION RESULTS, ALLEN COMMUNICATED TO THE REPORTER THAT ANY PAL STIRRUPS WITH THE MISSING CYLINDER GUARD SHOULD BE TAKEN OUT OF USE UNTIL THEY ARE REPAIRED.

    Description of Event or Problem · 1

    ON (B)(6), ALLEN MEDICAL WAS CALLED BY A CUSTOMER WITH A PAL STIRRUP REPAIR REQUEST. AT THAT TIME THE CALLER STARTED THE STIRRUP AND BEEN INVOLVED WITH AN OPERATING ROOM TECH INJURY. NO PATIENT WAS INVOLVED. THE OPERATING ROOM TECH'S HAND HAD BEEN PINCHED BETWEEN THE STIRRUP'S GAS CYLINDER AND ROD. THE TECH WAS CONFIRMED TO HAVE A HAIRLINE FRACTURE IN HER THUMB WITH SOME NERVE DAMAGE, SHE SAID. THERE IS RESIDUAL NUMBNESS AND SHE IS STILL BEING TREATED FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN PAL STIRRUPS POWER ASSISTED LITHOTOMY STIRRUPS FWZ ALLEN MEDICAL SYSTEMS A-10023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK