BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2842907 · Received November 21, 2012

    Report

    Report Number
    3005075853-2012-05297
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    February 29, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE PATIENT HAVE A NICKEL ALLERGY? WHAT WAS THE REASON FOR THE CHOLECYSTECTOMY PROCEDURE? WHAT IS LEADING THE SURGEON TO BELIEVE THE PATIENT IS HAVING AN ALLERGIC REACTION? WAS A CT SCAN OR BLOOD TEST PERFORMED? EES RISK MANAGER SPOKE TO THE ASSOCIATE AT THE INSURANCE COMPANY AND SHE INDICATED THE PATIENT IS CURRENTLY BACK IN THE HOSPITAL BEING REEVALUATED FOR ABDOMINAL PAIN. THEY ARE PROCURING CLIPS TO PERFORM A SKIN ALLERGY TEST. THE INSURANCE COMPANY CONTACTED EES TO PROVIDE AN UPDATE. SHE INDICATED THE PATIENT'S MOTHER CALLED HER AND RELAYED THAT THE PATIENT IS TPN (TOTAL PARENTERAL NUTRITION) AND THERE IS A PICC LINE INFECTION. SHE DID NOT KNOW THE STATUS OF ANY ALLERGY TEST OR IF THEY ARE MOVING FORWARD WITH THE TESTING. I PROVIDED THIS INFORMATION TO EES MEDICAL DIRECTOR TO GET CLARIFICATION AND HE PROVIDED THE FOLLOWING: WITHOUT ANY OBJECTIVE EVIDENCE, THE IDEA OF CLIP ALLERGY HAS BEEN RAISED BY ONE OF HER HEALTHCARE PROVIDERS. RECENTLY, EES HAS BEEN MADE AWARE THAT THE PATIENT WAS ALSO UNDERGOING TOTAL PARENTERAL NUTRITIONAL SUPPORT THROUGH A PICC LINE. THIS SEEMS TO INDICATE A MORE COMPLEX PROBLEM THAN CLIP ALLERGY AND MAY POINT TO OTHER CAUSES OF HER POST OPERATIVE COURSE THAT AT THIS TIME WE HAVE LIMITED INFORMATION REGARDING. THE INSURANCE COMPANY HAS AGREED TO INFORM EES IF THE ALLERGY TESTING IS CONDUCTED AS WELL AS THE RESULTS. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WAS PERFORMED ON (B)(6), 2012. THE PROCEDURE WENT WELL AND THERE WAS NO PATIENT CONSEQUENCE. THE PATIENT HAS SINCE BEEN RE-ADMITTED SEVERAL TIMES FOR ABDOMINAL PAIN. IT IS THE SURGEON'S OPINION THAT THE PATIENT MAY HAVE AN ALLERGIC REACTION TO THE CLIPS USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization