BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT

    MDR report key: 18210186 · Received November 27, 2023

    Report

    Report Number
    9610617-2021-00023
    Event Type
    Injury
    Date Received
    November 27, 2023
    Date of Event
    February 4, 2021
    Report Date
    November 28, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CHANGE OF LEADING DEVICE AND CONCOMMITANT DEVICES (UPDATED D4; D10). CORRECTION OF MANUFACTURING SITE NUMBER (CORRECT NUMBER: 9610617). BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 22-0074 CORRECTIVE ACTION 6. AFTER PRODUCT EVALUATION, THERE WAS NO PRODUCT MALFUNCTION IDENTIFIED WHICH WOULD CAUSE SERIOUS INJURY. COMPLAINT NOT VERIFIED - NO OVERHEATING ISSUES WERE DETECTED DURING TESTING WITH THE EQUIPMENT THAT WAS RETURNED TO KSI. THE FOLLOWING EQUIPMENT WAS RETURNED TO KSI FOR THE COMPLAINT INVESTIGATION: 1) TC201US - SERVICE ORDER: 6226675, SERIAL NUMBER: XQ816484-P. 2) TC304US - SERVICE ORDER: 6226676, SERIAL NUMBER: (B)(6) TH120 - SERVICE ORDER: (B)(4), SERIAL NUMBER: (B)(6) TH120 - SERVICE ORDER: (B)(4), SERIAL NUMBER: (B)(6) . THE ABOVE-MENTIONED EQUIPMENT WAS TESTED TOGETHER OVER TWO DAYS WITHOUT ISSUE. EACH CAMERA WAS BURNED-IN OVERNIGHT, BUT THE SYSTEM OPERATING TEMPERATURES NEVER CAME CLOSE TO A POINT THAT COULD CAUSE A BURN. FURTHERMORE, THE EQUIPMENT RETURNED TO KSI DOES NOT CONTACT THE PATIENT, SO THESE FOUR ITEMS ARE UNLIKELY TO BE THE SOURCE OF ANY POTENTIAL BURNS. A REVIEW OF DHRS FOR ALL MATERIAL SHOWS NO DISCREPANCIES OR INDICATIONS THAT THE DEVICES ARE RELATED TO THIS ISSUE. BASED ON THE INFORMATION ABOVE, IT CAN BE CONCLUDED THAT THE PRODUCTS DID NOT CONTRIBUTE TO THE INCIDENT.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MDR 9610617-2021-00023 THERE WAS A MISTAKE IN THE TEXT IN SECTION B5. THEREFORE, THE TEXT IN SECTION B5 HAS BEEN CORRECTED AND THIS CORRECTION SUPPLEMENTAL IS SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EQUIPMENT WAS PART OF A MEDICAL POTENTIAL MEDICAL INCIDENT. 2 PATIENTS GOT BURNED DURING CASES ON (B)(6) 2021. THE TWO INCIDENTS OCCURED ON THE SAME DAY. BOTH THE FIRST AND THE SECOND CASE WAS A SEPTORHINOPLASTY OR SINUS SURGERY. THE "SMALL RED BLEMISH" WAS DISCOVERED POST-OP NO SORES, NO BLISTERING, JUST ALITTLE DISCOLORATION. NO DRAPE OR OTHER ACCESSORY WAS INVOLVED. THE CASE HAD BEEN COMPLETED AND THERE IS NO INFORMATION OF ANY PATIENT FOLLOW-UP. THE SURGERY IS INSIDE THE NOSE AND THIS WAS ON THE OUTSIDE PART OF THE NOSE. DOCTORS PERSONAL OPINION IT LOOKS LIKE FRICTION WHICH IS NORMAL IN SINUS CASES. THIS EVENT INVOLVES A TOTAL OF 7 ITEMS OF WHICH 961976 IS THE CAUSE OF THE BURN. THERE WILL BE NO SEPARATE REPORT FOR 961896, 961894, 961895, 961893, 961889, 961892 AS THIS ITEMS WERE INVOLVED IN THIS INCIDENT. THIS INCIDENT WAS REPORTED IN 2021 UNDER FOLLOWING MDRS: 961889: 2027009-2021-00023 961892: 2027009-2021-00026 HOWEVER, THE MANUFACTURING SITE NUMBER "2027009" STATED IN THESE MDRS WAS WRONG. THE CORRECT MANUFACTURING SITE NUMBER IS "9610617". THEREFORE, THE NUMBER HAS BEEN CHANGED IN THIS MEDWATCH AND THIS REPORT HAD TO BE SUBMITTED AS "INITIAL". COMUNICATION WILL BE DONE IN THIS CASE 961889: 9610617-2021-00023 ONLY NOW. 961892: 9610617-2021-00026 WON´T BE PROCEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EQUIPMENT WAS PART OF A MEDICAL POTENTIAL MEDICAL INCIDENT. 2 PATIENTS GOT BURNED DURING CASES ON 2/4/21. THE TWO INCIDENTS OCCURED ON THE SAME DAY. BOTH THE FIRST AND THE SECOND CASE WAS A SEPTORHINOPLASTY OR SINUS SURGERY. THE "SMALL RED BLEMISH" WAS DISCOVERED POST-OP NO SORES, NO BLISTERING, JUST ALITTLE DISCOLORATION. NO DRAPE OR OTHER ACCESSORY WAS INVOLVED. THE CASE HAD BEEN COMPLETED AND THERE IS NO INFORMATION OF ANY PATIENT FOLLOW-UP. THE SURGERY IS INSIDE THE NOSE AND THIS WAS ON THE OUTSIDE PART OF THE NOSE. DOCTORS PERSONAL OPINION IT LOOKS LIKE FRICTION WHICH IS NORMAL IN SINUS CASES. THIS EVENT INVOLVES A TOTAL OF 7 ITEMS OF WHICH 961976 IS THE CAUSE OF THE BURN. THERE WILL BE NO SEPARATE REPORT FOR 961896, 961894, 961895, 961893, 961889, 961892 AS THIS ITEMS WERE INVOLVED IN THIS INCIDENT. THIS INCIDENT WAS REPORTED IN 2021 UNDER FOLLOWING MDRS: 961889: 2027009-2021-00023. 961892: 2027009-2021-00026. THE MANUFACTURING SITE NUMBER "2027009" STATED IN THESE MDRS WAS WRONG. THE CORRECT MANUFACTURING SITE NUMBER IS "9610617". THEREFORE THE NUMBER HAS BEEN CHANGED IN THIS MEDWATCH. COMUNICATION WILL BE DONE IN THIS CASE 9610617-2021-00023 (NOTIFICATION # 961976) ONLY NOW. 9610617-2021-00026 WON´T BE PROCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239426 LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT FIBER OPTIC LIGHT CABLE FCW KARL STORZ SE & CO. KG 495ND VQ29

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other 7230AA - HOPKINS TELESCOPE 0°, 4 MM, 18 CM| 7230BA - HOPKINS TELESCOPE 30°, 4 MM, 18 CM| 7230CA - HOPKINS TELESCOPE 70°, 4 MM, 18 CM| TC201US - CCU, MODULAR, IMAGE1 S CONNECT II,| TH120 - ASM,HEAD,IMAGE 1 S, 4U| TL300 - COLD LIGHT FOUNTAIN POWER LED 300