BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB040, 5MMX45CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 13639873 · Received March 1, 2022

    Report

    Report Number
    2027111-2022-00424
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Report Date
    April 22, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    PMA / PMN Number
    K062169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT NUMBER HAS BEEN PROVIDED TO APPLIED MEDICAL. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY DAMAGES OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: THE PROCEDURES WERE A MIX OF ROUX EN Y, TRADITIONAL DUODENAL SWITCH, AND MODIFIED DUODENAL SWITCH. DETAILED DESCRIPTION OF EVENT: COMPLAINT 1 OF 6: #2022-000332 - CB040 LOT # UNKNOWN, COMPLAINT 2 OF 6: #2022-000333 - CB040 LOT # UNKNOWN, COMPLAINT 3 OF 6: #2022-000334 - CB040 LOT # UNKNOWN, COMPLAINT 4 OF 6: #2022-000335 - CB040 LOT # UNKNOWN, COMPLAINT 5 OF 6: #2022-000336 - CB040 LOT # UNKNOWN, AND COMPLAINT 6 OF 6: #2022-000337 - CB040 LOT # UNKNOWN. 6 EA. UNITS OF CB040 BLADE TIPS DID NOT CUT DURING USE IN PROCEDURE. USER COMPLAINS OF TISSUE SNAGGING AT THE BLADE TIPS INSTEAD OF CUTTING. NO PATIENT INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07FEB2022 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER: "I DON'T HAVE AN EXACT NUMBER OF PROBLEM SCISSORS, BUT 6 HAVE BEEN MENTIONED AS HAVING BEEN REPLACED DURING A CASE." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 24FEB2022 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER: THE LOT NUMBER OF THE DEVICES ARE UNKNOWN. NO SPECIFIC DATES ARE KNOWN, BUT THE SURGEON EXPERIENCED THE ISSUE MULTIPLE TIMES IN THE 2-3 WEEKS PRIOR TO THE COMPLAINT BEING SUBMITTED. THE PROCEDURES WERE A MIX OF ROUX EN Y, TRADITIONAL DUODENAL SWITCH, AND MODIFIED DUODENAL SWITCH. THE SURGEON OPENED ANOTHER SCISSOR AND CONTINUED WITH THE CASE EACH TIME. PRODUCTS ARE NOT AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OCCURRED. TYPE OF INTERVENTION: THE SURGEON OPENED ANOTHER SCISSOR AND CONTINUED WITH THE CASE EACH TIME.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: THE PROCEDURES WERE A MIX OF ROUX EN Y, TRADITIONAL DUODENAL SWITCH, AND MODIFIED DUODENAL SWITCH. DETAILED DESCRIPTION OF EVENT: COMPLAINT 1 OF 6: #2022-000332 - MFR 2027111-2022-00434. COMPLAINT 2 OF 6: #2022-000333 - MFR 2027111-2022-00423. COMPLAINT 3 OF 6: #2022-000334. COMPLAINT 4 OF 6: #2022-000335 - MFR 2027111-2022-00425. COMPLAINT 5 OF 6: #2022-000336 - MFR 2027111-2022-00427. COMPLAINT 6 OF 6: #2022-000337 - MFR 2027111-2022-00428. 6 EA. UNITS OF CB040 BLADE TIPS DID NOT CUT DURING USE IN PROCEDURE. USER COMPLAINS OF TISSUE SNAGGING AT THE BLADE TIPS INSTEAD OF CUTTING. NO PATIENT INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07FEB2022 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER: "I DON'T HAVE AN EXACT NUMBER OF PROBLEM SCISSORS, BUT 6 HAVE BEEN MENTIONED AS HAVING BEEN REPLACED DURING A CASE." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 24FEB2022 FROM [NAME], APPLIED MEDICAL ACCOUNT MANAGER: THE LOT NUMBER OF THE DEVICES ARE UNKNOWN. NO SPECIFIC DATES ARE KNOWN, BUT THE SURGEON EXPERIENCED THE ISSUE MULTIPLE TIMES IN THE 2-3 WEEKS PRIOR TO THE COMPLAINT BEING SUBMITTED. THE PROCEDURES WERE A MIX OF ROUX EN Y, TRADITIONAL DUODENAL SWITCH, AND MODIFIED DUODENAL SWITCH. THE SURGEON OPENED ANOTHER SCISSOR AND CONTINUED WITH THE CASE EACH TIME. PRODUCTS ARE NOT AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OCCURRED. TYPE OF INTERVENTION: THE SURGEON OPENED ANOTHER SCISSOR AND CONTINUED WITH THE CASE EACH TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304265 CB040, 5MMX45CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB040 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown