Single Use Aspiration Needle NA-201SX-4022 (UDI 04953170180972)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170180972), received between May 29, 2020 and Feb 2, 2024 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE ASPIRATION NEEDLE BROKE OFF. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE. THE NEEDLE DID NOT BREAK OFF INSIDE THE PATIENT OR THE SCOPE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629699 ↗
• InjuryOct 17, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, DURING THE MIDDLE OF A DIAGNOSTIC BRONCHOSCOPY WITH A LINEAR EBUS THE TIP OF THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT'S RIGHT HILAR REGION AND HAD TO BE RETRIEVED. BIOPSY FORCEPS WERE USED TO RETRIEVE THE DEVICE FRAGMENT. THE PATIENT HAD A POST-PROCEDURE CHEST RADIOGRAPH. THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND NO ISSUES IDENTIFIED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE, OLYMPUS19G EBUS NEEDLE. THERE WAS A FIVE (5) MINUTE DELAY WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA DUE TO THE DEVICE MALFUNCTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 15614792 ↗
• InjuryOct 17, 2022Break

  THE CUSTOMER REPORTED TO OLYMPUS, DURING THE MIDDLE OF A DIAGNOSTIC BRONCHOSCOPY WITH A LINEAR EBUS THE TIP OF THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT'S RIGHT HILAR REGION AND HAD TO BE RETRIEVED. BIOPSY FORCEPS WERE USED TO RETRIEVE THE DEVICE FRAGMENT. THE PATIENT HAD A POST-PROCEDURE CHEST RADIOGRAPH. THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND NO ISSUES IDENTIFIED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE, OLYMPUS19G EBUS NEEDLE. THERE WAS A FIVE (5) MINUTE DELAY WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA DUE TO THE DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614786 ↗
• MalfunctionMar 8, 2022Break; Break

  THE CUSTOMER REPORTED THAT THE DISTAL TIP OF NEEDLE BROKE UPON INITIAL INJECTION INTO THE PATIENT DURING A UNSPECIFIED THERAPEUTIC PROCEDURE. THE TIP WAS REMOVED FROM THE PATIENT WITH OLYMPUS 1.9MM DISPOSABLE FORCEPS WITHOUT FURTHER INCIDENT OR DAMAGE TO THE PATIENT¿S AIRWAY FROM A VISUAL INSPECTION. THE PROCEDURE WAS SLIGHTLY DELAYED FOR THE RECOVERY OF THE BROKEN TIP. A VISUAL BRONCHOSCOPIC INSPECTION WAS PERFORMED TO CONFIRM THE PATIENTS AIRWAY WAS CLEAR AND UNDAMAGED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT DEATH, HARM, OR INJURIES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13688700 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "EVALUATION OF THE SAFETY AND EFFICACY OF MINIMAL ENDOSCOPIC SPHINCTEROTOMY FOLLOWED BY PAPILLARY BALLOON DILATION FOR THE REMOVAL OF COMMON BILE DUCT STONES". THE LITERATURE REPORTED THE RESULT OF 435 PATIENTS WITH MEDIASTINAL AND HILAR LYMPHADENOPATHY WHO UNDERWENT ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURE USING THE OLYMPUS NA-201SX-4022 FROM MAY 2010 TO JULY 2012. IN THE LITERATURE, IT WAS REPORTED COMPLICATION AS FOLLOWS; FEVER AFTER EBUS-TBNA (110 CASES). BLOOD CULTURE SAMPLES POSITIVE (2 CASES): THE IDENTIFIED ORGANISM WAS NORMAL FLORA OF THE SKIN AND THERE WAS NO TRUE BACTEREMIA. PNEUMONIA (2 CASES). MEDIASTINAL ABSCESS (1 CASE): A (B)(6) FEMALE PATIENT WITH UNDERLYING DIABETES MELLITUS DEVELOPED FEVER 3 DAYS AFTER THE PROCEDURE, AT WHICH TIME SHE WAS DIAGNOSED WITH MEDIASTINAL ABSCESS. AFTER 7 DAYS OF ANTIBIOTIC THERAPY, THE PATIENT BECAME AFEBRILE. THE PATIENT WAS SUCCESSFULLY TREATED WITH ANTIBIOTICS FOR 6 WEEKS. OMSC ASSUMES THAT THE MEDIASTINAL ABSCESS WAS A SERIOUS INJURY DUE TO THE REQUIRED 7DAYS OF ANTIBIOTIC THERAPY. THERE ARE NOT MENTIONED THAT THESE COMPL

  Patient problems: Abscess; Fever

  MAUDE report 12286210 ↗
• MalfunctionFeb 5, 2021Break; Break

  AFTER THE PROCEDURE IT WAS NOTICED THAT THE NEEDLE WAS FRACTURED. THE PROCEDURE BEING PERFORMED WAS A DIAGNOSTIC BRONCHOSCOPY. THERE WERE NO OTHER DEVICES INVOLVED IN THE EVENT. IT IS UNKNOWN WHETHER THERE WAS ANY DELAY IN THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. THE DEVICE FAILED IN THE MIDDLE OF THE PROCEDURE. THERE WAS NO BLEEDING. THE PATIENT IS CURRENTLY STABLE. THE NEEDLE WAS FRACTURED WHEN BIOPSIES OF THE LEVEL 4R NODE WERE BEING PERFORMED. THE ISSUE MAY HAVE BEEN IN CONTACT WITH A CARTILAGINOUS RING DURING THE NEEDLE PASS HOWEVER, NOTHING OUT OF THE ORDINARY WAS BEING DONE AND THE APPROACH WAS VERY STANDARD. PER THE USER FACILITY, THIS IS THE FIRST TIME THEY HAVE EXPERIENCED THE PROBLEM. THERE WAS NO OBVIOUS ISSUE WITH THE NEEDLE PRIOR TO USE. THE FOLLOW UP X-RAY DID NOT SHOW ANY RETAINED MATERIAL. THE NEEDLE HAD LIKELY PERFORMED APPROXIMATELY SIX PASSES OF OTHER SITES PRIOR TO THE ISSUE. NO MEDICAL INTERVENTION WAS NEEDED AFTER THE PATIENT COUGHED UP THE NEEDLE TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11289941 ↗
• MalfunctionSep 14, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS), THE NEEDLE BECAME STUCK IN THE TRACHEAL WALL AND THEN BROKE. SUBSEQUENTLY THE NEEDLE WAS RETRIEVED. ALTHOUGH REQUESTED ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532319 ↗
• MalfunctionJun 9, 2020Break; Device Fell; Break; Device Fell

  IT WAS REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) PROCEDURE, THE USER DETERMINED THAT THE NEEDLE WAS NOT VISIBLE BEYOND THE SHEATH WHEN IT WAS ADVANCED. THE USER LOOKED EVERYWHERE , USED ULTRASOUND TO CHECK ALL THE PUNCTURE SITES INCLUDING FLUORO CHECKS. THE USER ENDED UP FINDING THE TIP OF THE NEEDLE ON THE BACK TABLE WHERE THE USER PREPARED THE TISSUE SAMPLES. ACCORDING TO THE REPORTER, THE USER SUSPECTED THAT THE NEEDLE MIGHT HAVE BROKEN IN THE PATIENT ON A PREVIOUS PASS AND GOT LODGED IN THE SHEATH, SLIPPED OUT DURING THE SAMPLE PREPARATION. THERE WAS NO PATIENT HARM OR IMPACT DUE TO THE INCIDENT. NO USER HARM OR INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10134691 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXCESS FORCE WAS REQUIRED TO DEPLOY THE NEEDLE DURING A LYMPHADENOPATHY. THE PROCEDURE WAS COMPLETED PLANNED. FOLLOWING THE PROCEDURE, THE USER EXPERIENCED A NEEDLE STICK AS THE NEEDLE WAS NOT RETRACTED INTO THE SHEATH WHEN IT WAS GIVEN TO HER. IT WAS NOTED THE CAUSE OF THIS IS UNKNOWN. AS A RESULT OF THE NEEDLE PUNCTURE, A REPORT WAS FILED IN HOUSE, THE USER RECEIVED A TETANUS SHOT AND WAS TESTED FOR HEPATITIS AND HIV ALONG WITH THE PATIENT. THEY BOTH TESTED NEGATIVE. THE USER IS IN STABLE CONDITION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10101618 ↗
• InjuryMay 29, 2020Activation, Positioning or Separation Problem

  CORRECTED DATA: F13- AWARE DATE SHOULD BE 22MAY2020 AS THIS EVENT BECAME REPORTABLE WITH NOTIFICATION THAT THE USER RECEIVED A TETANUS SHOT.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 10101603 ↗