SINGLE USE ASPIRATION NEEDLE
Report
- Report Number
- 3011050570-2025-00165
- Event Type
- Death
- Date Received
- February 25, 2025
- Report Date
- November 5, 2025
- Manufacturer
- GYRUS ACMI, INC.
- Product Code
- KTI
- PMA / PMN Number
- K163469
- Removal / Correction Number
- 3011050570-07/21/2025-00
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE WAS NOT RETURNED TO OLYMPUS. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.
CORRECTION IS BEING MADE TO PREVIOUSLY SUBMITTED G3 - DATE RECEIVED BY MANUFACTURER. THE CORRECT DATE WAS 03 OCT 2024. CORRECTION TO H6. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER AND THE RESULTS OF THE APPROVED FINAL INVESTIGATION. THE ITEM INVOLVED IN THE CUSTOMER REPORT WAS NOT RECEIVED BY OLYMPUS. A NEEDLE WAS RECEIVED FOR INVESTIGATION, BUT IT DOES NOT CORRESPOND TO THE ITEM REFERENCED BY THE CUSTOMER. THEREFORE, A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE AFFECTED PRODUCT WAS UNABLE TO BE PERFORMED. AN IMAGE OF THE REMOVED COMPONENT WAS SHARED BY THE CUSTOMER. OLYMPUS OBTAINED A 19G LASER CUT HYPOTUBE COMPONENT AND STRETCHED IT USING PLIERS IN ATTEMPT TO REPLICATE THE OBJECT IN THE IMAGE. THE STRETCHED HYPOTUBE LOOKED LIKE THE COMPONENT REMOVED FROM THE PATIENT. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE MALFUNCTION WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THAT SEVERAL MONTHS AFTER A PATIENT UNDERWENT AN ENDOBRONCHIAL ULTRASOUND (EBUS), A PART OF THE NEEDLE WAS FOUND IN THE PATIENT¿S RIGHT MAIN BRONCHUS. THE PATIENT HAD APPROXIMATELY FOUR ADMISSIONS FOR POST-TREATMENT INFECTIONS. THE PATIENT EXPERIENCED A POST-TREATMENT LOCULATED PNEUMOTHORAX, WHICH WAS MANAGED CONSERVATIVELY, FOLLOWED BY ADMISSION AND TREATMENT WITH A DRAIN FOR EMPYEMA WITH PNEUMOTHORAX. THE PATIENT HAD TWO FURTHER ADMISSIONS, PRESUMED TO BE DUE TO ONGOING EMPYEMA. HOWEVER, THE RADIOLOGIST NOTICED A FOREIGN BODY IN THE PATIENT'S LYMPH NODE. THIS APPEARED BETWEEN THE INITIAL STAGING COMPUTED TOMOGRAPHY (CT) AND THE POST-TREATMENT CT, WITH THE ONLY INTERVENTION THE PATIENT HAD BEING THE EBUS PROCEDURE. THE PATIENT WAS NOTED TO BE COUGHING A LOT DURING THE PROCEDURE, AND IT WAS NOT WELL TOLERATED. A BRONCHOSCOPY WAS PERFORMED BUT WAS UNABLE TO SAFELY REMOVE THE FOREIGN BODY. THE FRAGMENT WAS REMOVED THROUGH THORACIC SURGERY. ON AN UNSPECIFIED DATE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. NO FURTHER INFORMATION WAS PROVIDED
IT WAS REPORTED THAT THE PATIENT UNDERWENT EBUS PROCEDURE IN (B)(6) 2024. THE PATIENT WAS RECOMMENDED RADIOLOGY/CHEMOTHERAPY TREATMENTS FOR CANCER, BUT TREATMENT WAS SUBSEQUENTLY DELAYED OR CANCELLED AS A RESULT OF ALLERGIC REACTIONS. IN APPROXIMATELY LATE OCTOBER OR EARLY (B)(6) 2024, THE HOSPITAL AT WHICH THE EBUS WAS PERFORMED WAS NOTIFIED BY ANOTHER LOCAL FACILITY THAT THE PATIENT HAD UNDERGONE A CT AND PET SCAN AT THAT FACILITY AND A DISLODGED ARTICLE WAS CONFIRMED IN RIGHT BRONCHUS. THE DATE OF PATIENT¿S DEATH WAS NOT REPORTED. THE CORONER¿S REPORT INDICATED CANCER AS CONCLUSION FOR CAUSE OF DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1088194 | SINGLE USE ASPIRATION NEEDLE | VIZISHOT 2 FLEX | KTI | GYRUS ACMI, INC. | NA-U403SX-4019 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention| D| H |