KARL STORZ INTUBATION ENDOSCOPE
Received Oct 17, 2024 · Event occurred Sep 11, 2024
Report MW5161199 · MDR key 20480584
Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2024; 11302BDX KARL STORZ INTUBATION ENDOSCOPE WITH SERIAL NUMBER (B)(6) ¿ SENT OUT FOR REPAIR. ISSUE WITH ENDOSCOPE WAS A FAULTY ELECTRICAL CONNECTION AND DEVICE WOULD NOT DISPLAY ON 2 DIFFERENT MONITORS. ON (B)(6)2024; RECEIVED 11302BDX KARL STORZ INTUBATION ENDOSCOPE WITH SERIAL NUMBER (B)(6) (SUPPOSED TO BE A BRAND-NEW ENDOSCOPE) AS AN EXCHANGE FOR THE DAMAGED ENDOSCOPE WITH SERIAL NUMBER (B)(6). ON (B)(6)2024; BORESCOPE WAS UTILIZED TO VISUALIZE INNER WORKINGS OF THE 11302BDX KARL STORZ INTUBATION ENDOSCOPE WITH SERIAL NUMBER (B)(6). DURING THE PROCESS, THE ENDOSCOPE HAD WHAT APPEARED TO BE PLASTIC PIECES AND SOME RED STREAK AREA INSIDE THE CHANNEL. ALSO, CONNECTION AREA INSIDE OF ENDOSCOPE APPEARED "ROUGH". (B)(6) 2024; ENDOSCOPE WAS NOT PLACED INTO SERVICE AND BIO-MED WAS NOTIFIED. (B)(6)2024; KARL STORZ REPRESENTATIVE CAME TO VIEW THE SCOPE USING THE BORESCOPE WITH THE SCOPE NURSE EDUCATOR AND TO VISUALIZE THE ISSUES REPORTED ON THE KARL STORZ INTUBATION ENDOSCOPE, MODEL 11302BDX WITH SERIAL NUMBER (B)(6). ON (B)(6)2024; RECEIVED ANOTHER 11302BDX KARL STORZ INTUBATION ENDOSCOPE WITH SERIAL NUMBER (B)(6) (WHICH AGAIN WAS SUPPOSED TO BE A BRAND-NEW ENDOSCOPE) TO REPLACE THE SERIAL NUMBER (B)(6); (B)(6)2024; 11302BDX KARL STORZ INTUBATION ENDOSCOPE WITH SERIAL NUMBER (B)(6) WAS VISUALIZED USING THE BORESCOPE. THIS ENDOSCOPE WAS ALSO NOTED TO HAVE WHAT LOOKED LIKE PLASTIC, HAIR, AND AGAIN A RED STREAK. 9/20/2024; EMAIL RECEIVED FROM (B)(4) SUGGESTING THAT IT WAS "MOST LIKELY FROM THE PACKAGING USED TO SHIP THE SCOPE. SHE RECOMMENDED CLEANING AND STERILIZING THE SCOPE, AND THEN CHECKING IT AGAIN. ON 9/20/2024, EMAIL SENT TO MANAGER REQUESTING HOW SHE WOULD LIKE US TO PROCEED WITH PROCESSING THE ENDOSCOPE. 9/20/2024; EMAIL RECEIVED BACK FROM (B)(4) REQUESTING THAT THE ENDOSCOPE BE CLEANED AND THEN TO RE-BORESCOPE THE DEVICE; (B)(6)2024; DEVICE WAS CLEANED AND THEN THE BORESCOPE WAS USED TO VISUALIZE THE INNER CHANNEL. IT WAS NOTED THAT WHAT HAD APPEARED AS PLASTIC AND HAIR HAD BEEN REMOVED BUT THE RED STREAK REMAINED. THE RED STREAK APPEARS TO LOOK LIKE A RUST STREAK. PICTURES CAN BE SENT IN PDF. REF REPORTS: MW5161200 AND MW5161201.