FDA Adverse Event Injury Summary report: N

SCOPE UC 190-1

MDR report key: 23415871 · Received October 29, 2025

Report

Report Number
MW5178193
Event Type
Injury
Date Received
October 29, 2025
Date of Event
October 23, 2025
Report Date
October 24, 2025
Manufacturer
OLYMPUS CORPORATION
Product Code
EOQ
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PER EVENT REPORT "WE SUCCESSFULLY MADE ABOUT 4 PASSES WITH 22G NEEDLE AND THEN HE REALIZED THE NEEDLE WAS DEPLOYING DIFFERENTLY. WE PULLED OUT THE NEEDLE AND THE SHEATH WAS NOT STAYING THE POSITION. THE SECOND NEEDLE HAD THE SAME ISSUE. UPON PULLING THE NEEDLE OUT AND INSPECTING THE SCOPE (UC 190-1), WE NOTICED THE BALLOON TIP WAS SEPARATED FROM SHAFT OF THE SCOPE. WE DID NOT CONTINUE TO USE THE SCOPE AND BROUGHT IN UC 190-2. DURING THE PROCEDURE, I ASKED PROVIDER WHAT THE DARK DEBRIS IN HER LUNGS WAS, NOT REALIZING IT WAS FLAKES FROM THE SCOPE. WE CONTINUED THE PROCEDURE, DID A TOTAL OF 40ML BAL, AND FINISHED THE PROCEDURE. UPON LOOKING AT THE PATIENT, SHE HAD GREY SOOT LIKE DEBRIS ON HER HEAD AND PILLOW, AND IT WAS THEN WE REALIZED IT WAS FROM THE SCOPE. THE LAVAGE TO BE SENT TO LAB WAS FULL OF BLACK DEBRIS. I IMMEDIATELY MADE PROVIDER AWARE OF THE SITUATION. PT WAS IN RECOVERY AT THIS TIME. RT CHARGE AND HOUSE SUPERVISOR NOTIFIED AND AFTER-HOURS CLINICAL ENGINEERING CALLED" PER PROVIDER DOCUMENTATION (B)(6): "EBUS / BRONCHOSCOPE PROCEDURE NOTE SERVICE: PULMONARY PRE-OP DIAGNOSIS: MEDIASTINAL ADENOPATHY POST-OP DIAGNOSIS: GRANULOMA ANESTHESIA/SEDATION: PLEASE SEE ANESTHESIOLOGY NOTE FOR DETAILS THE RISKS, BENEFITS, COMPLICATIONS, TREATMENT OPTIONS AND EXPECTED OUTCOMES WERE DISCUSSED WITH THE MEDICAL DECISION MAKER. THE POSSIBILITIES OF REACTION TO MEDICATION, PULMONARY ASPIRATION, PERFORATION OF A VISCUS, BLEEDING, FAILURE TO DIAGNOSE A CONDITION AND CREATING A COMPLICATION REQUIRING TRANSFUSION OR OPERATION WERE DISCUSSED WITH THE PATIENT/DECISION MAKER WHO FREELY SIGNED THE CONSENT. DESCRIPTION OF PROCEDURE: PRIOR TO THE PROCEDURE, A TIME OUT WAS DONE. DURING THE PROCEDURE, THE PATIENT WAS UNDER FULL MONITORING WITH TELEMETRY, ECG, PULSE OXYMETRY, HEART RATE, AND BLOOD PRESSURE. USING A FIBEROPTIC BRONCHOSCOPE, THE ENTIRE AIRWAY WAS CAREFULLY INSPECTED AND THERE WERE NO ENDOBRONCHIAL LESIONS. AIRWAYS WERE SUCTIONED CLEARED OF SECRETIONS. THE SECOND PROCEDURE CONSISTED OF USING THE EBUS (ENDOBRONCHIAL ULTRASOUND) BRONCHOSCOPY TO IDENTIFY LYMPH NODE STATIONS THIS SAMPLE WAS ALSO SENT FOR FLOW CYTOMETRY, AFB (ACID-FAST BACILLI), FUNGAL STAIN CULTURE WE THEN DEFLATED THE ULTRASOUND BALLOON AND REMOVED THE ULTRASOUND-GUIDED SCOPE. WE REINSERTED THE REGULAR BRONCHOSCOPE AND SUCTIONED OUT A SMALL AMOUNT OF BLOODY SECRETIONS, ALONG WITH BLACK-COLORED PARTICLES, WHICH WAS CLEARED BY SUCTIONING. WE THEN INSPECTED FOR BLEEDING AND FOUND NONE. AFTER 5 PASSES, THE TIP OF THE EBUS SCOPE WAS THEN NOTED TO BE SEPARATED, NEW EBUS SCOPE WAS USED FOR THE REST OF THE PROCEDURE THEN A RIGHT UPPER LOBE BAL WAS PERFORMED, WITH 40 ML AND RETURN OF 20 ML. THE SPECIMEN WAS SENT FOR AFB, FUNGAL CULTURE SENSITIVITY THE SCOPE WAS THEN REMOVED. THE PATIENT WAS THEN AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. X-RAY CHEST DATA ORDERED UPDATE NOTE FROM PROVIDER (B)(6): "I CALLED [REDACTED] TODAY POST BRONCHOSCOPY PROCEDURE. PATIENT IS DOING WELL; SHE HAS NOT STARTED THE PREDNISONE YET. WILL BE FILLING IT UP TODAY. I ALSO DISCUSSED HER ABOUT THE MILD SEPARATION OF THE TIP OF THE BRONCHOSCOPE SHEATH, AND WE REPLACED IT WITH ANOTHER SCOPE TO FINISH THE PROCEDURE. I ADVISED JUST FOR PRECAUTION WE WILL DO ANOTHER CT OF THE CHEST TO ASSESS. MS. (B)(6) UNDERSTOOD AND AGREED TO GET THE CT SCAN. I ALSO DISCUSSED WITH MS. (B)(6) SON AND EXPLAINED THE INCIDENCE. WILL FOLLOW HER UP NEXT WEEK IN THE OFFICE FOR THE BIOPSY RESULTS". A 57 YEAR OLD PLEASANT FEMALE WAS SEEN BY PULMONOLOGIST IN OFFICE WITH THE COMPLAINTS OF SHORTNESS OF BREATH COUGH PRODUCTION OF MUCUS SECRETION FOR SEVERAL MONTHS. SHE WAS PLACED ON THE NASAL SPRAYS SYMBICORT ALBUTEROL WITHOUT ANY IMPROVEMENT. SUBSEQUENTLY HAD A CT SCAN OF THE CHEST DONE WHICH REVEALED MEDIASTINAL ADENOPATHY. SHE DENIES ANY HISTORY OF COCCI BEFORE. PATIENT WAS SCHEDULED FOR EBUS FNA (FINE NEEDLE ASPIRATION). COMPLETED (B)(6) 2025.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1562805 SCOPE UC 190-1 BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ OLYMPUS CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 57 YR Female Required Intervention