BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE 3.5 ULTEM KOH-EFF

    MDR report key: 13279699 · Received January 18, 2022

    Report

    Report Number
    1216677-2021-00321
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    December 13, 2021
    Report Date
    July 11, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    PMA / PMN Number
    K143650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION, NO SAMPLE RETURNED , REVIEW DHR , ANALYSIS AND FINDINGS. DISTRIBUTION HISTORY. THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 06/24/21 UNDER WORK ORDER (B)(4) REVIEW OF FG INVENTORY REVEAL THAT LOT 307280 WAS DEPLETED. MANUF. RECORD REVIEW DHR - 307280 WAS REVIEWED AND WAS FOUND TO HAVE NON-CONFORMITY UNRELATED TO THE COMPLAINT CONDITION. THE WORK ORDER WAS REWORKED AND SUBSEQUENTLY RESUBMITTED FOR QC INSPECTION AND PASSED. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HIST. RECORD SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. THIS COMPLAINT CONDITION IS AN ISOLATED EVENT. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. THERE IS CURRENTLY NO RMA FOR THE PRODUCT. VISUAL EVAL. EVALUATION OF THE COMPLAINT UNIT COULD NOT BE COMPLETED AS THE COMPLAINT UNIT HAS NOT BEEN RETURNED. IF THE UNIT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. HOWEVER, PHOTOS WHERE ATTACHED AND PROVIDED WITH THE COMPLAINTS. COMPLAINT CONDITION WILL BE CONSIDERED AS VERIFIED BASED ON THE PHOTO. FUNCTIONAL EVALUATION EVALUATION OF THE COMPLAINT UNIT COULD NOT BE COMPLETED AS THE COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE UNIT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. THE CUFF PART NUMBER 38265 DID NOT UNDERGO ANY DESIGN CHANGE. THE CUFF IS MADE FROM HS-714, A CLASS VI BIO COMPATIBILITY FOR PLASTICS, PASSING ISO10993-5 CYTOTOXICITY TEST. ADDITIONALLY, A REVIEW OF THE VALIDATED ASSEMBLY PROCESS AT THE MANUFACTURING FACILITY DID NOT REVEAL ANY POTENTIAL GAPS WHEREBY THE HEATSHRINK CUFF COULD NOT HAVE BEEN SHRUNK IN PLACE. DURING THE REVIEW OF THE PROVIDED INFORMATION, IT IS NOTED IN THE COMPLAINT DETAILS THAT THE UTERINE BALLOON WAS INFLATED WITH 20CC OF SALINE. THE IFU (38501-IFU-B) STATES THAT THE UTERINE TIP BALLOON TO BE FILLED WITH UP TO 10CC OF AIR. IT IS UNKNOWN WHAT EFFECTS 20CC OF SALINE IN THE BALLOON COULD CAUSE. THE COMPLAINT DETAILS ALSO STATES THAT THE ADVINCULA DELINEATOR WAS SUTURED IN PLACE. THE IFU DOES NOT INDICATE NOR GIVE INSTRUCTIONS FOR SUTURING THE DEVICE IN PLACE. IT IS UNKNOWN IF THE SUTURING OF THE PRODUCT IN PLACE PLACES OR ADDS ADDITIONAL FORCES TO THE DEVICE THAT IS NOT WITHIN THE INTENDED USE OF THE PRODUCT, HOWEVER, IT MAY HAVE LEAD TO THE FAILURE OF THE DEVICE. CORRECTIVE ACTIONS: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT DETERMINED TO BE A MANUFACTURING ISSUE. AS A PRECAUTION, A QUALITY ALERT (QA-00393) WAS CREATED TO ALERT THE MANUFACTURING FLOOR OF THE COMPLAINT CONDITION. THE PRODUCT MET THE REQUIRED RELEASE SPECIFICATIONS PER DHR REVIEW. NO RE-TRAINING REQUIRED. *WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    WE WERE GIVEN VERY MINIMAL INFORMATION FROM THE (B)(6) CLINIC. ALL THEY TOLD US IS THAT A DELINEATOR TIP WAS FOUND INTRA-UTERINE BY PATHOLOGY AFTER A TLH. FOLLOW-UP: PATIENT HAD LAPAROSCOPIC HYSTERECTOMY DUE TO MENORRHAGIA AND DYSMENORRHEA. SURGERY WAS PERFORMED WITHOUT COMPLICATION. PATHOLOGY DISCOVERED A FOREIGN OBJECT WITHIN THE UTERUS SPECIMEN. STERILE 3-5 ULTEM KOH-EFF AD750-KE35 E-COMPLAINT- (B)(4).

    Description of Event or Problem · 0

    WE WERE GIVEN VERY MINIMAL INFORMATION FROM THE CLEVELAND CLINIC. ALL THEY TOLD US IS THAT A DELINEATOR TIP WAS FOUND INTRA-UTERINE BY PATHOLOGY AFTER A TLH. FOLLOW-UP: PATIENT HAD LAPAROSCOPIC HYSTERECTOMY DUE TO MENORRHAGIA AND DYSMENORRHEA. SURGERY WAS PERFORMED WITHOUT COMPLICATION. PATHOLOGY DISCOVERED A FOREIGN OBJECT WITHIN THE UTERUS SPECIMEN. OPEN-SIDED SPECULUM WAS PLACED IN PATIENT'S VAGINA WITH CLEAR VISUALIZATION OF THE CERVIX. THE ANTERIOR LIP OF THE CERVIX WAS GRASPED WITH A SINGLE TOOTH TENACULUM. MEDIUM ADVINCULA DELINEATOR SELECTED (3.5CM). CERVIX DILATED GENTLY WITH HANK DILATORS TO ALLOW PLACEMENT OF MANIPULATOR. THE INTRAUTERINE BALLOON WAS FILLED WITH 20CC OF SALINE. STITCH OF 0-VICRYL PLACED. ADVINCULA DELINEATOR WAS SUTURED IN PLACE ONCE THE CUP WAS FLUSH AGAINST CERVIX. SPECULUM WAS REMOVED. CLEVELAND CLINIC HAS PULLED ALL DELINEATOR OFF OF THE SHELVES UNTIL THEY RECEIVE A REPORT BACK FROM COOPERSURGICAL EXPLAINING WHAT HAPPENED. THEY ARE ASKING WHAT THE WHITE PLASTIC SLEEVE IS MADE OF AND WHAT IS ITS FUNCTIONAL PURPOSE ON THE DELINEATOR. THEY ARE ALSO ASKING IF WE HAVE SEEN THIS HAPPEN BEFORE. THE FIRST THREE PHOTOS WITH A RULER ARE FROM PATHOLOGY. THE LAST TWO IMAGES WITH A BEIGE BACKGROUND ARE IMAGES OF A DIFFERENT DELINEATOR THAT WAS USED TO DEMONSTRATE WHAT THEY BELIEVE THE PIECE ORIGINATED FROM. STERILE 3-5 ULTEM KOH-EFF AD750-KE35 E-COMPLAINT-2021-12-0000578.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172438 STERILE 3.5 ULTEM KOH-EFF STERILE 3.5 ULTEM KOH-EFF HEW COOPERSURGICAL, INC. AD750-KE35 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other