BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL SCISSORS

    MDR report key: 5502902 · Received March 15, 2016

    Report

    Report Number
    9611102-2016-00004
    Event Type
    Injury
    Date Received
    March 15, 2016
    Date of Event
    December 7, 2015
    Report Date
    June 1, 2018
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    KBD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ACTUAL DEVICE SENT TO MANUFACTURER ON 16MAR2016. INVESTIGATION/EVALUATION CURRENTLY IN PROCESS. MDR EXEMPTION NUMBER E2015039. (B)(4).

    Additional Manufacturer Narrative · 0

    FOLLOW UP #2. RWGMBH RECEIVED A VOLUNTARY EVENT REPORT (MW507475) ON 16FEB2018 THAT WAS COMPLETED BY THE PATIENT. RWGMBH CONSIDERS THIS REPORT CLOSED. IF ANY ADDITIONAL INFORMATION REGARDING THIS EVENT IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) (IMPORTER) SUBMITTING REPORT ON BEHALF OF RICHARD WOLF (RWGMBH) (MANUFACTURER).

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #3, THE FOLLOWING SECTIONS WERE UPDATED: MEDWATCH MW (B)(4) IS ATTACHED. IF ANY ADDITIONAL INFORMATION REGARDING THIS EVENT IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF (RW GMBH) (MANUFACTURER). - ATTACHMENT: [MEDWATCH (B)(4).PDF].

    Description of Event or Problem · 0

    (B)(4). FACILITY REPORTED ONE OF THE SCISSOR TINES BROKE OFF INSIDE OF PATIENTS NASAL CAVITY DURING PROCEDURE. AN X-RAY AND AN ENT SURGEON WAS REQUIRED TO REMOVED FOREIGN OBJECT. IN ADDITION, PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE DUE TO ADDITIONAL SURGERY AND PROLONGED OPERATING TIME.

    Description of Event or Problem · 0

    FOLLOW UP #2.

    Description of Event or Problem · 0

    FOLLOW-UP #3 06-21-2018. MEDWATCH REPORT MW (B)(4) WAS SENT TO RWMIC FROM FDA, INFORMATION RECEIVED ON 06/01/2018. DETAILS OF THE MEDWATCH REPORT ARE BELOW AND ARE ALSO ATTACHED, SEE SECTION H10. HOSPITAL HAD MADE IT UNAVAILABLE TO US. I WENT IN FOR EXPLORATORY CEREBRAL SINUS FLUID LEAK SURGERY AT 6PM ON MONDAY, (B)(6) 2015. DURING THE SURGERY THE SURGEON SAW A THIN CSF PULSATION IN THE UPPER LEFT NASAL AREA. HE WENT TO MAKE A PATCH FROM THIN TISSUE IN THE LINING OF THE RIGHT NOSTRIL. AS HE WENT TO CUT THE SOFT TISSUE FROM THE RIGHT NOSTRIL, THE TIP OF THE CURVED NASAL SCISSOR BROKE OFF AND FELL. THEY DID IMMEDIATE X-RAYS OF THE STOMACH AND LUNGS, NOT KNOWING WHERE THE SCISSOR TIPS HAD FALLEN. THEY EVENTUALLY FOUND THE TIP BEHIND MY ADENOIDS AND CALLED IN ANOTHER SURGEON. THEY HEAD-LOCKED ME AND THE NEW SURGEON PUT HIS HANDS IN AND UP MY THROAT, USING TOOLS AS WELL, TO TRY TO RETRIEVE THE SCISSOR TIP FRAGMENT. IT TOOK HRS FOR THEM TO RETRIEVE THE SCISSOR TIPS, HEAD-LOCKING AND WHIPLASHING MY HEAD AND NECK. I CAME OUT OF THE SURGERY AROUND 11:30PM, INTUBATED BECAUSE OF THE SURGEON'S WORRIES MY THROAT WOULD SWELL SHUT FROM THE TRAUMA. I WAS MANUALLY BAGGED DOWN THE HALL INTO MY ICU ROOM, WHERE I STAYED INTUBATED UNTIL LATE MORNING ON (B)(6) 2015. I WOKE UP WITH EXTREME FACIAL PAIN AND A HEADACHE, NOT EVEN TOUCHABLE WITH MEDICINE. THEY LEFT ME IN ICU UNTIL LATE WEDNESDAY, (B)(6) 2015, THEM MOVED ME TO THE POST-NEUROSURGERY SPECIAL CARE UNIT FOR ANOTHER 48 HRS. THEY DISCHARGED ME FRIDAY, (B) (6) 2015. FROM THE MOMENT THE TIPS OF THE SCISSORS BROKE OFF DURING SURGERY, AROUND 7:45P MONDAY (B) (6) 2015 UNTIL MY DISCHARGE, FRIDAY (B) (6) 2015, (B) (6) COVERED MY HOSPITAL COSTS. TO THIS DAY I CONTINUE TO HAVE NECK PAIN AND A CHRONIC HEADACHE, AS WELL AS FACIAL NUMBING IN CERTAIN AREAS AND NEUROLOGICAL ISSUES, DUE TO THIS SURGERY. I HAVE NOT BEEN WELL SINCE I WOKE UP ON (B) (6) 2015. CONCOMITANT MEDICAL: DICLOFENAC, HIZENTRA, NEUROSTIMULATOR. INITIAL REPORTER INFORMATION: (B)(6). OCCUPATION: PATIENT. EMAIL: (B)(6). PHONE: (B)(6).

    Additional Manufacturer Narrative · 1

    INVESTIGATION REPORT COMPLETED 05/13/2016. CAUSE OF THE BREAK APPEARS TO BE MATERIAL FATIGUE DUE TO NORMAL WEAR AND TEAR, DEVICE IS OVER 15 YEARS OLD. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IE INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RW (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT ADDITIONAL INFORMATION IS RECEIVED, RW (B)(4) WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION. (B)(4).

    Description of Event or Problem · 1

    DEVICE WAS LABELED SUCH THAT IT INDICATED IT WAS LAST REPAIRED IN 1988. HARDNESS TEST WAS PERFORMED ON DEVICE AND PASSED CURRENT SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156591 NASAL SCISSORS NASAL SCISSORS KBD RICHARD WOLF GMBH 8211.221

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R PROBIOTIC| SINGULAIR| VYFELMA