Single Use Aspiration Needle NA-201SX-4021 (UDI 04953170240935)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04953170240935), received between Apr 2, 2019 and Sep 22, 2026 — classified as 10 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that the needle broke involving an Olympus Single Use Aspiration Needle. The issue occurred during a diagnostic Endobronchial Ultrasound (EBUS) procedure. The procedure was completed using a similar device. There were no reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852791 ↗
• MalfunctionApr 14, 2026Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE-USE ASPIRATION NEEDLE'S INSERTION PORTION EXTENDED THROUGH BOTH THE HYPODERMIC TUBE AND SHEATH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24876926 ↗
• MalfunctionNov 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE SHEATH HAD SHEARED AT THE TIP. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC ENDOBRONCHIAL ULTRASOUND (EBUS). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644875 ↗
• MalfunctionSep 15, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050620 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE HAD THE TWO OF THE NEEDLES BREAKING THROUGH SHEATH COMING OUT THE SIDE OF THE SHEATH, DAMAGING THE SCOPE. THE ISSUE WAS FOUND DURING THE DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537847 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE HAD THE TWO OF THE NEEDLES BREAKING THROUGH SHEATH COMING OUT THE SIDE OF THE SHEATH, DAMAGING THE SCOPE. THE ISSUE WAS FOUND DURING THE DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537832 ↗
• MalfunctionMar 25, 2025Material Puncture/Hole; Material Puncture/Hole

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689360 ↗
• InjuryFeb 12, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE NEEDLE BROKE AND FELL INTO THE PATIENT'S LYMPH NODE DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE NEEDLE WAS RETRIEVED WITH BIOPSY FORCEPS AND A PORTABLE X-RAY CONFIRMED NO RESIDUAL NEEDLE WAS LEFT IN THE PATIENT. IT WAS REPORTED THERE WAS A DELAY FOR ABOUT TEN MINUTES TO REPLACE THE NEEDLE AND REMOVE THE NEEDLE PIECE. THE PATIENT RECEIVED FENTANYL AND VERSED SEDATION FOR THE PROCEDURE. THERE WAS NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368301 ↗
• MalfunctionNov 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT, THE SINGLE USE ASPIRATION NEEDLE BECAME DETACHED IN THE OPERATING CHANNEL OF THE FIBERSCOPE. IT DID NOT COME OUT OF THE CHANNEL INTO THE PATIENT, BUT WAS REMOVED BY THE OPERATORS¿ HANDS. THE ISSUE OCCURRED, AT THE END OF THERAPEUTIC BRONCHIAL FIBROSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20707713 ↗
• InjurySep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING FROM THE SUBJECT DEVICE BECAME STUCK IN THE PATIENT'S AIRWAY PASSAGE AT THE THIRD PASS DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE. IT WAS FURTHER CLARIFIED THAT THE SPRING FELL IN THE PATIENT AND WAS RETRIEVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED AND NO IMPACT ON THE PATIENT WAS REPORTED. THERE WERE NO REPORTS OF ANY FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170109 ↗
• MalfunctionJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE OF THE SHEATH WAS STRIPPED AND FELL OFF AND REQUIRED URGENT RETRIEVAL. THE ISSUE OCCURRED DURING A LINEAR ENDOBRONCHIAL ULTRASOUND (EBUS) DIAGNOSTIC PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE AND THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR SEVERAL MINUTES. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE, AND THE DAMAGED NEEDLE WAS DISCARDED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755230 ↗
• InjuryMay 1, 2024Break; Break

  IT WAS REPORTED THE SPRING FROM THE SUBJECT DEVICE WAS LEFT INSIDE THE PATIENT DURING A ENDOBRONCHIAL ULTRASONOGRAPHY PROCEDURE (EBUS). AFTER THE EBUS PORTION WAS COMPLETED AND A REGULAR BRONCHOSCOPE WAS INTRODUCED, IT WAS DISCOVERED THAT THE SPRING FELL OFF. THE SPRING WAS RETRIEVED THROUGH THE BRONCHOSCOPE WITH A GRASPING FORCEPS THAT TOOK MULTIPLE ATTEMPTS RESULTING IN A 25 MINUTE DELAY. THE PATIENT'S HEALTH AND THE OUTCOME OF THE PROCEDURE WAS NOT IMPACTED AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. WHILE THE PATIENT WAS IN RECOVERY A X-RAY WAS PERFORMED AND THE PATIENT WAS DISCHARGED TO HOME WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226307 ↗
• InjuryNov 27, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE TIP BROKE AND FELL IN THE PATIENT'S TRACHEA DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION ( EBUS-TBNA) FOR TREATMENT OF HEMOPTYSIS. THE PHYSICIAN IMMEDIATELY USED THE BIOPSY FORCEPS TO CLAMP OUT THE TIP CAUSING A LONGER EXAMINATION TIME OF ABOUT 10-MINUTES AND INCREASED BLEEDING. OLYMPUS RECEIVED FURTHER INFORMATION INDICATING THAT THE INCREASED BLEEDING WAS NOT CAUSED BY THE NEEDLE TIP FALLING IN THE PATIENT'S TRACHEA AND THAT THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THE INCIDENT. THE ESTIMATED BLOOD LOSS WAS 5 ML. NO FURTHER INTERVENTIONS WERE GIVEN FOR THE BLEED. IT WAS CONFIRMED THAT THE TIP WAS REMOVED WITH BIOPSY FORCEPS. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213589 ↗
• InjurySep 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS RECEIVED A MEDWATCH MW5120181 REPORTING THAT THE SINGLE USE ASPIRATION NEEDLE WAS USED FOR APPROXIMATELY SEVEN PASSES INTO THE LYMPH NODES DURING A PROCEDURE WITHOUT ANY INDICATION OF AN ISSUE. ON THE LAST PASS, IT WAS NOTED THAT THE NEEDLE TIP WAS UNATTACHED FROM ITS SHAFT AND IN THE LUNG TISSUE. IT WAS INTACT AND RECOVERED BY THE PHYSICIAN USING BRONCHIAL FORCEPS. ALL PARTS OF THE DEVICE WERE INSPECTED AND FOUND INTACT WITHOUT FRAGMENTATION POST PROCEDURE. THE PHYSICIAN ALSO PERFORMED A COMPLETE AIRWAY INSPECTION, ORDERED A POST-PROCEDURE CHEST X-RAY, AND DISCUSSED IT WITH THE PATIENT'S FAMILY IN THE POST PROCEDURE CONFERENCE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CLARIFIED THAT THE PROCEDURE PERFORMED WAS A DIAGNOSTIC BRONCHOSCOPY WITH ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION, WHICH WAS EXTENDED BY FIVE MINUTES AND WAS COMPLETED WITH ANOTHER DEVICE. THE DIAGNOSTIC OUTCOME AND PATIENT'S CONDITION WERE NOT IMPACTED BY THE FAILURE. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720740 ↗
• InjurySep 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS RECEIVED A MEDWATCH MW5120181 REPORTING THAT THE SINGLE USE ASPIRATION NEEDLE WAS USED FOR APPROXIMATELY SEVEN PASSES INTO THE LYMPH NODES DURING A PROCEDURE WITHOUT ANY INDICATION OF AN ISSUE. ON THE LAST PASS, IT WAS NOTED THAT THE NEEDLE TIP WAS UNATTACHED FROM ITS SHAFT AND IN THE LUNG TISSUE. IT WAS INTACT AND RECOVERED BY THE PHYSICIAN USING BRONCHIAL FORCEPS. ALL PARTS OF THE DEVICE WERE INSPECTED AND FOUND INTACT WITHOUT FRAGMENTATION POST PROCEDURE. THE PHYSICIAN ALSO PERFORMED A COMPLETE AIRWAY INSPECTION, ORDERED A POST-PROCEDURE CHEST X-RAY, AND DISCUSSED IT WITH THE PATIENT'S FAMILY IN THE POST PROCEDURE CONFERENCE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CLARIFIED THAT THE PROCEDURE PERFORMED WAS A DIAGNOSTIC BRONCHOSCOPY WITH ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION, WHICH WAS EXTENDED BY FIVE MINUTES AND WAS COMPLETED WITH ANOTHER DEVICE. THE DIAGNOSTIC OUTCOME AND PATIENT'S CONDITION WERE NOT IMPACTED BY THE FAILURE. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720724 ↗
• InjuryMay 17, 2023Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE USING THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE WITH A SINGLE USE ASPIRATION NEEDLE, THERE WAS RESISTANCE. IT WAS INITIALLY STATED THERE WAS A HOLE ON THE INSERTION CHANNEL. ADDITIONAL INFORMATION WAS OBTAINED TO CLARIFY THE EVENT. UPON THE FIRST PASS WITH THE FIRST NEEDLE, THE PHYSICIAN MET RESISTANCE, SO THE PASS WAS STOPPED. THE NEEDLE WAS TAKEN OUT OF THE SCOPE, AND IT WAS NOTICED THAT THE END OF THE CATHETER WAS BROKEN OFF AND THE METAL TIP WAS STICKING OUT. THE NEEDLE WAS PLACED ASIDE. A SECOND NEEDLE WAS USED, AND ANOTHER PASS WAS TRIED. RESISTANCE WAS FELT AGAIN, SO THE NEEDLE WAS PULLED OUT. THE SCOPE WAS REMOVED, AND THE PHYSICIAN TRIED TO PUT THE CATHETER DOWN THE SCOPE OUTSIDE OF THE PATIENT AND COULD NOT ADVANCE THE NEEDLE TO THE END OF THE SCOPE. A SECOND SCOPE WAS USED WITH ANOTHER (THIRD) NEEDLE TO FINISH THE PROCEDURE, AND IT WAS NOT CANCELLED. DUE TO THE PRODUCT ISSUES, THE PROCEDURE WAS PROLONGED BY ABOUT 30-40 MINUTES. IT WAS REPORTED THAT THE SCOPE WAS PLUGGED INTO THE TOWER, AND THERE WERE NO ERROR MESSAGES ASSOCIATED WITH THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950897 ↗
• InjuryMay 17, 2023Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE USING THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE WITH A SINGLE USE ASPIRATION NEEDLE, THERE WAS RESISTANCE. IT WAS INITIALLY STATED THERE WAS A HOLE ON THE INSERTION CHANNEL. ADDITIONAL INFORMATION WAS OBTAINED TO CLARIFY THE EVENT. UPON THE FIRST PASS WITH THE FIRST NEEDLE, THE PHYSICIAN MET RESISTANCE, SO THE PASS WAS STOPPED. THE NEEDLE WAS TAKEN OUT OF THE SCOPE, AND IT WAS NOTICED THAT THE END OF THE CATHETER WAS BROKEN OFF AND THE METAL TIP WAS STICKING OUT. THE NEEDLE WAS PLACED ASIDE. A SECOND NEEDLE WAS USED, AND ANOTHER PASS WAS TRIED. RESISTANCE WAS FELT AGAIN, SO THE NEEDLE WAS PULLED OUT. THE SCOPE WAS REMOVED, AND THE PHYSICIAN TRIED TO PUT THE CATHETER DOWN THE SCOPE OUTSIDE OF THE PATIENT AND COULD NOT ADVANCE THE NEEDLE TO THE END OF THE SCOPE. A SECOND SCOPE WAS USED WITH ANOTHER (THIRD) NEEDLE TO FINISH THE PROCEDURE, AND IT WAS NOT CANCELLED. DUE TO THE PRODUCT ISSUES, THE PROCEDURE WAS PROLONGED BY ABOUT 30-40 MINUTES. IT WAS REPORTED THAT THE SCOPE WAS PLUGGED INTO THE TOWER, AND THERE WERE NO ERROR MESSAGES ASSOCIATED WITH THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950896 ↗
• InjuryMay 17, 2023Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE USING THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE WITH A SINGLE USE ASPIRATION NEEDLE, THERE WAS RESISTANCE. IT WAS INITIALLY STATED THERE WAS A HOLE ON THE INSERTION CHANNEL. ADDITIONAL INFORMATION WAS OBTAINED TO CLARIFY THE EVENT. UPON THE FIRST PASS WITH THE FIRST NEEDLE, THE PHYSICIAN MET RESISTANCE, SO THE PASS WAS STOPPED. THE NEEDLE WAS TAKEN OUT OF THE SCOPE, AND IT WAS NOTICED THAT THE END OF THE CATHETER WAS BROKEN OFF AND THE METAL TIP WAS STICKING OUT. THE NEEDLE WAS PLACED ASIDE. A SECOND NEEDLE WAS USED, AND ANOTHER PASS WAS TRIED. RESISTANCE WAS FELT AGAIN, SO THE NEEDLE WAS PULLED OUT. THE SCOPE WAS REMOVED, AND THE PHYSICIAN TRIED TO PUT THE CATHETER DOWN THE SCOPE OUTSIDE OF THE PATIENT AND COULD NOT ADVANCE THE NEEDLE TO THE END OF THE SCOPE. A SECOND SCOPE WAS USED WITH ANOTHER (THIRD) NEEDLE TO FINISH THE PROCEDURE, AND IT WAS NOT CANCELLED. DUE TO THE PRODUCT ISSUES, THE PROCEDURE WAS PROLONGED BY ABOUT 30-40 MINUTES. IT WAS REPORTED THAT THE SCOPE WAS PLUGGED INTO THE TOWER, AND THERE WERE NO ERROR MESSAGES ASSOCIATED WITH THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950893 ↗
• InjuryMay 17, 2023Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  A COMPANY REPRESENTATIVE, ON BEHALF OF A USER FACILITY, REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE USING THE EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE WITH A SINGLE USE ASPIRATION NEEDLE, THERE WAS RESISTANCE. IT WAS INITIALLY STATED THERE WAS A HOLE ON THE INSERTION CHANNEL. ADDITIONAL INFORMATION WAS OBTAINED TO CLARIFY THE EVENT. UPON THE FIRST PASS WITH THE FIRST NEEDLE, THE PHYSICIAN MET RESISTANCE, SO THE PASS WAS STOPPED. THE NEEDLE WAS TAKEN OUT OF THE SCOPE, AND IT WAS NOTICED THAT THE END OF THE CATHETER WAS BROKEN OFF AND THE METAL TIP WAS STICKING OUT. THE NEEDLE WAS PLACED ASIDE. A SECOND NEEDLE WAS USED, AND ANOTHER PASS WAS TRIED. RESISTANCE WAS FELT AGAIN, SO THE NEEDLE WAS PULLED OUT. THE SCOPE WAS REMOVED, AND THE PHYSICIAN TRIED TO PUT THE CATHETER DOWN THE SCOPE OUTSIDE OF THE PATIENT AND COULD NOT ADVANCE THE NEEDLE TO THE END OF THE SCOPE. A SECOND SCOPE WAS USED WITH ANOTHER (THIRD) NEEDLE TO FINISH THE PROCEDURE, AND IT WAS NOT CANCELLED. DUE TO THE PRODUCT ISSUES, THE PROCEDURE WAS PROLONGED BY ABOUT 30-40 MINUTES. IT WAS REPORTED THAT THE SCOPE WAS PLUGGED INTO THE TOWER, AND THERE WERE NO ERROR MESSAGES ASSOCIATED WITH THIS EVEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950886 ↗
• MalfunctionNov 11, 2022Retraction Problem; Retraction Problem

  A MEDWATCH REPORT WAS RECEIVED BY OLYMPUS INDICATING, WHEN THE SURGEON PROCEEDED TO USE A 21G ASPIRATION NEEDLE DURING BRONCHOSCOPY, THE NEEDLE WOULD NOT PROTRUDE OUT OF SHEATHE AND SO WAS UNABLE TO TAKE A BIOPSY OF LYMPH NODE TWICE. THERE WAS NO SURGICAL DELAY AND NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15784693 ↗
• MalfunctionAug 11, 2022Mechanical Problem; Material Deformation; Material Twisted/Bent; Mechanical Problem; Material Deformation; Material Twisted/Bent

  AS REPORTED, AT PREPARATION BEFORE USE FOR A THERAPEUTIC LYMPH NODE PUNCTURE PROCEDURE (PATIENT WAS UNDER ANESTHESIA), THE NEEDLE ADJUSTER COULD NOT BE LOCKED OR UNLOCKED. NO INJURY REPORTED. THE USER COMPLETED THE CASE WITH ANOTHER DEVICE AND WITH NO DELAY OF MORE THAN FIFTEEN (15) MINUTES. THERE WAS NO PATIENT HARM AND NO INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214561 ↗
• MalfunctionDec 15, 2020Break; Break

  WE RECEIVED THE FOLLOWING REPORT. *DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EUS-TBNA), THE SUBJECT DEVICE WAS USED. WHEN THE USER INSERTED THE NEEDLE INTO THE TISSUE, IT WAS FOUND THAT THE BUCKLE WAS NOT FIXED, WHICH COULD NOT CONTROL THE LENGTH OF THE NEEDLE. AS A RESULT, THE NEEDLE NEARLY PIERCED THE BLOOD VESSELS. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11009832 ↗
• MalfunctionApr 2, 2019Break; Break

  OLYMPUS WAS INFORMED THAT DURING A ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, A PORTION OF THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT. AN X-RAY WAS PERFORMED TO LOCATE THE DEVICE FRAGMENT; HOWEVER, EFFORTS WERE UNSUCCESSFUL AND THE FRAGMENT WAS NOT RETRIEVED. IT WAS REPORTED THAT PRIOR TO THE BREAKAGE THE DEVICE HAD COMPLETED TWO SUCCESSFUL PASSES. THERE WERE NO ISSUES OR DIFFICULTIES EITHER INSERTING OR WITHDRAWING THE DEVICE AT ANY POINT IN THE PROCEDURE. THERE WAS A LOW DEGREE OF ANGULATION IN THE SCOPE WHEN THE NEEDLE WAS INSERTED. NO OTHER ISSUES OR UNUSUAL PHENOMENA OCCURRED DURING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THE PATIENT¿S CURRENT CONDITION IS STABLE WITH NO BLEEDING AND NO COUGH. ADDITIONALLY, THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE WITH NO ANOMALIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8476409 ↗