BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ER SPEC MED NON-STERILE

    MDR report key: 12851658 · Received November 22, 2021

    Report

    Report Number
    1216677-2021-00251
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 26, 2021
    Report Date
    November 12, 2021
    Manufacturer
    COOPERSURGICAL , INC.
    Product Code
    HIB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION NO SAMPLE RETURNED REVIEW DHR INSPECT STOCK PRODUCT *ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM COOPERSURGICAL SISTER COMPANY (OBP) AND SOLD TO THE CUSTOMER UNDER LOT NUMBER 21A1102Z. MANUFACTURING RECORD REVIEW DHR FOR LOT NUMBER 21A1102Z WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW IQC RECORD-21-08-03-006 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. HOWEVER, THERE WAS INVENTORY OF THE REPORTED LOT NUMBER. VISUAL INSPECTION OF 32 PIECES (C=0 SAMPLING PLAN, AQL=0.40, N=160) DID NOT FIND ANY BROKEN SPECULUMS. FUNCTIONAL EVALUATION EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. HOWEVER, THERE WAS INVENTORY OF THE REPORTED LOT NUMBER. FUNCTIONAL INSPECTION OF 32 PIECES (C=0 SAMPLING PLAN, AQL=0.40, N=160) FOUND ALL SPECULUMS FUNCTIONED AS INTENDED. ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. HOWEVER, IT WAS SUSPECTED IF THE BOTTOM ORANGE TAB (USED TO SLIDE THE TOP BLADE UP OR DOWN) WAS COMPLETELY MOVED IN THE UP DIRECTION AND WAY BEYOND THE NOTCHES THEN THE TOP BLADE WILL DETACH FROM THE BOTTOM BLADE AND THIS WOULD BE CONSIDERED USER ERROR. *WAS THE COMPLAINT CONFIRMED? NO *CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS A ROOT CAUSE COULD NOT BE RELIABLY DETERMINED.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    CUSTOMER STATED - LOT # 21A1102Z FOR ITEM # C020110-1 WAS REPORTED BY THE EMERGENCY DEPARTMENT THAT ON THREE OCCASIONS THE ITEM BROKE IN HALF WHEN IN USE AND IN ONE CASE THE PRODUCT BROKE IN THE PATIENT. BROKEN PIECE ON SPECULUM RETRIEVED WITHOUT INJURY TO PATIENT. (B)(6) 2021- FOLLOW-UP RESPONSE- WAS THERE ANY ADVERSE EFFECT AS A RESULT OF REPORTED CONDITION? NO *WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? NO *WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? PELVIC EXAM *DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/WAS THERE ANY FRAGMENT LEFT IN THE PATIENT? NO EXTRA STEPS NEEDED TO COMPLETE PROCEDURE. BROKEN PIECE ON SPECULUM RETRIEVED WITHOUT INJURY TO PATIENT * WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? 30 MINUTES DELAY? 5-10 MINUTES APPROXIMATELY TO FIND ADDITIONAL SPECULUM THAT WAS NOT BROKEN AND COMPLETE EXAM. 1216677-2021-00251 ER SPEC MED NON-STERILE C020110-1 E-COMPLAINT- (B)(6).

    Description of Event or Problem · 0

    CUSTOMER STATED : LOT # 21A1102Z FOR ITEM # (B)(4) WAS REPORTED BY THE EMERGENCY DEPARTMENT THAT ON THREE OCCASIONS THE ITEM BROKE IN HALF WHEN IN USE AND IN ONE CASE THE PRODUCT BROKE IN THE PATIENT. BROKEN PIECE ON SPECULUM RETRIEVED WITHOUT INJURY TO PATIENT. ON (B)(6) 2021: FOLLOW-UP RESPONSE: WAS THERE ANY ADVERSE EFFECT AS A RESULT OF REPORTED CONDITION? NO. WAS THERE ANY ADDITIONAL MEDICAL ATTENTION? NO. WHAT PROCEDURE WAS THE PHYSICIAN PERFORMING? PELVIC EXAM. DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE/HOW DID PHYSICIAN COMPLETE THE PROCEDURE/WAS THERE ANY FRAGMENT LEFT IN THE PATIENT? NO EXTRA STEPS NEEDED TO COMPLETE PROCEDURE. BROKEN PIECE ON SPECULUM RETRIEVED WITHOUT INJURY TO PATIENT. WAS THERE ANY SIGNIFICANT DELAY AS RESULT OF THE REPORTED CONDITION? 30 MINUTES DELAY? 5-10 MINUTES APPROXIMATELY TO FIND ADDITIONAL SPECULUM THAT WAS NOT BROKEN AND COMPLETE EXAM. ER SPEC MED NON-STERILE C020110-1 E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756204 ER SPEC MED NON-STERILE ER SPEC MED NON-STERILE HIB COOPERSURGICAL , INC. C020110-1 -

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other