BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS SHEATH CH10-12 45

    MDR report key: 6085100 · Received November 8, 2016

    Report

    Report Number
    9610711-2016-00031
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 12, 2016
    Report Date
    January 12, 2017
    Manufacturer
    COLOPLAST A/S
    Product Code
    FED
    PMA / PMN Number
    K102485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THIS COMPLAINT WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT ON THIS LOT N°. CHECKING THE QUALITY DATABASES REVEALED NO RECORDED ANOMALY IN CONNECTION WITH THE DESCRIBED INCIDENT. WE RECEIVED AN OPENED RETAIL BOX LABELLED AXXL10 LOT N°5081300 CONTAINING AN USED SAMPLE. AT VISUAL EXAMINATION, NO ANOMALY COULD BE OBSERVED. WE SUBMITTED TO OUR WORKSHOP MANAGER WHO CONFIRMED THAT THE SAMPLE WAS CONFORMED TO OUR SPECIFICATION. THE DESCRIBED INCIDENT HAS NOT BEEN REPRODUCED ON THE RETURNED USED SAMPLE. WE BELIEVE THAT THE ROOT CAUSE IS DUE TO PATIENT'S ANATOMY (USER). BASED ON THE ABOVE THIS COMPLAINT IS NOT CONFIRMED AS A PRODUCT DEFECT.

    Description of Event or Problem · 1

    IN A FLEXIBLE URETEROSCOPY : PROBLEMS WITH THE SHEATH AXXL10 , THE SHEATH TIP WAS DEFECTIVE (CRACKED). IN ITS INTRODUCTION, IT TORN THE BLADDER NECK BECAUSE THE GUIDE IS PASSED THROUGH THE CRACK. RISK OF CAILLOTAGE THEY PROVIDED THE NECESSARY EQUIPMENT TO BE ABLE TO SOLVE THIS PROBLEM DOCTOR WAS FORCED TO MAKE AN ADDITIONAL SURGERY NAMELY ENDOSCOPIC RESECTION TO COAGULATE BLEEDING. PATIENT PATHOLOGY (INDICATION)? KIDNEY LITHIASIS. COMPLICATED ANATOMY? DIFFICULTY PASSING THE NECK OF THE BLADDER. LARGE BLADDER NECK. HAVE YOU ENCOUNTERED DIFFICULTIES IN CYSTOSCOPY? NO. WHAT KIND OF GUIDE WAS USED (BRAND) ? TERUMO. WHAT DIAMETER OF THE GUIDE? 0035. WHAT IS CRACKED TIP EXACTLY? IS IT FOR THE DISTAL TIP? ABNORMAL CRACK (MORE WIDE) AT THE TIP OF THE MANDREL: THE GUIDE WENT OUT OF THE MANDREL DURING INSERTION, CAUSING A TEAR OF THE BLADDER NECK WAS SHARP OBJECT USED WITH RETRACE? NO. DIAMETER URETEROSCOPE USED? DIGITAL STORZ. WHAT STAGE OF FLEXIBLE URETEROSCOPY THE INCIDENT HAPPENED ? IN THE INITIAL INSERTION OF THE SHEATH ENDOSCOPIC RESECTION OF BLADDER NECK? NO, ELECTROCOAGULATION WITH THE BALL OF RESECTOR WAS THE INTERVENTION FINISHED ? YES, ANOTHER SHEATH WAS USED. WAS A JJ IMPLANTED AT THE END OF THE INTERVENTION? YES + 1 CATHETER 3 WAYS FOR BLADDER IRRIGATION CLINICAL IMPLICATIONS? 1 NIGHT EXTRA HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737997 ACCESS SHEATH CH10-12 45 URETHRAL ACCESS SHEATH FED COLOPLAST A/S AXXL101002 5081300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other