Single Use Aspiration Needle NA-201SX-4021 (UDI 04953170381911)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04953170381911), received between Sep 17, 2019 and Sep 16, 2025 — classified as 6 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE PROTRUDES DIRECTLY BEHIND THE END OF THE METAL SPIRAL TUBE THROUGH THE PLASTIC TUBE. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PUNCTION LYMPH NODE PROCEDURE WHILE THE PATIENT WAS UNDER SEDATION - DEVICE OUTSIDE PATIENT AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23061786 ↗
• MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BRONCHIAL ENDOSCOPY PROCEDURE, WHEN REMOVING THE VACUUM SYRINGE TO DEPOSIT THE SAMPLE, PART OF THE NEEDLE OF THE SUBJECT DEVICE BECAME DETACHED FROM THE HANDLE. THE NEEDLE WAS ABLE TO BE RECOVERED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345118 ↗
• MalfunctionFeb 12, 2025Retraction Problem; Retraction Problem

  NO ADDTIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365660 ↗
• MalfunctionAug 31, 2024Unstable; Unstable

  IT WAS REPORTED WHEN PUNCTURING LYMPH NODES WITH THE SINGLE-USE ASPIRATION NEEDLE, THE KNOB DOES NOT SECURE THE NEEDLE TO THE ENDOSCOPE. THEREFORE, THE NEEDLE COULD NO LONGER BE BLOCKED/STABILIZED DURING SAMPLING. THE DEFECT WAS NOTICED AT THE BEGINNING OF THE DIAGNOSTIC PROCEDURE DURING THE FIRST LYMPH NODE PUNCTURE, SO THE OPERATING TIME WAS EXTENDED BY A FEW MINUTES. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113817 ↗
• MalfunctionAug 28, 2024Unstable; Unstable

  IT WAS REPORTED WHEN PUNCTURING LYMPH NODES WITH THE SINGLE-USE ASPIRATION NEEDLE, THE KNOB DOES NOT SECURE THE NEEDLE TO THE ENDOSCOPE. THEREFORE, THE NEEDLE COULD NO LONGER BE BLOCKED/STABILIZED DURING SAMPLING. THE DEFECT WAS NOTICED AT THE BEGINNING OF THE DIAGNOSTIC PROCEDURE DURING THE FIRST LYMPH NODE PUNCTURE, SO THE OPERATING TIME WAS EXTENDED BY A FEW MINUTES. THERE WAS NO REPORTED PATIENT IMPACT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088961 ↗
• MalfunctionAug 20, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE SINGLE-USE ASPIRATION NEEDLE CAN NO LONGER BE BLOCKED/STABILIZED DURING SAMPLING. THE KNOB CAN NO LONGER SECURE THE NEEDLE IN THE ENDOSCOPE. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE INVOLVING THE PUNCTURE OF LYMPH NODES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20004893 ↗
• InjuryApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHEN USING THE SINGLE USE ASPIRATION NEEDLE, THE PHYSICIAN ASPIRATED A SAMPLE FROM A LYMPH NODE, REMOVED THE NEEDLE AND HANDED IT TO A MEMBER OF THE BRONCH TEAM. THE TEAM MEMBER WENT TO EXTRACT THE CONTENTS OF THE NEEDLE INTO THE SPECIMEN CUP WHEN THEY NOTED THAT THE NEEDLE WAS HARD TO MOVE IN AND OUT OF THE SHEATH. THEY THEN TRIED TO PUT THE GUIDEWIRE BACK IN BUT WERE UNABLE TO. THEY THEN PUSHED THE "NEEDLE" OUT NOTING THAT THERE WAS NO LONGER A SHARP END BUT A BLUNT "CUT OFF STUMP". THEY INFORMED THE PHYSICIAN WHO INVESTIGATED WITH A BRONCHOSCOPE AND FOUND THE NEEDLE STUCK IN THE PATIENT'S LUNG. IT WAS EXTRACTED VIA FORCEPS. THE REPORTED EVENT CAUSED A DELAY IN THE PROCEDURE WHILE THE PATIENT WAS UNDER MODERATE SEDATION. THE PRODUCT WAS DISPOSED OF IN A SHARPS CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19186207 ↗
• InjuryApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHEN USING THE SINGLE USE ASPIRATION NEEDLE, THE PHYSICIAN ASPIRATED A SAMPLE FROM A LYMPH NODE, REMOVED THE NEEDLE AND HANDED IT TO A MEMBER OF THE BRONCH TEAM. THE TEAM MEMBER WENT TO EXTRACT THE CONTENTS OF THE NEEDLE INTO THE SPECIMEN CUP WHEN THEY NOTED THAT THE NEEDLE WAS HARD TO MOVE IN AND OUT OF THE SHEATH. THEY THEN TRIED TO PUT THE GUIDEWIRE BACK IN BUT WERE UNABLE TO. THEY THEN PUSHED THE "NEEDLE" OUT NOTING THAT THERE WAS NO LONGER A SHARP END BUT A BLUNT "CUT OFF STUMP". THEY INFORMED THE PHYSICIAN WHO INVESTIGATED WITH A BRONCHOSCOPE AND FOUND THE NEEDLE STUCK IN THE PATIENT'S LUNG. IT WAS EXTRACTED VIA FORCEPS. THE REPORTED EVENT CAUSED A DELAY IN THE PROCEDURE WHILE THE PATIENT WAS UNDER MODERATE SEDATION. THE PRODUCT WAS DISPOSED OF IN A SHARPS CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19186153 ↗
• MalfunctionFeb 5, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED, THE ENDO-THERMAL ASPIRATION NEEDLE LOCKING MECHANISM WAS NOT WORKING DURING BEGINNING OF AN ENDOBRONCHIAL ULTRASOUND (DIAGNOSTIC) PROCEDURE. THE REPORTED ISSUE OCCURRED OUT OF BOX, INITIAL CLINICAL USE. THERE WAS NO DELAY REPORTED. 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 18639675 ↗
• MalfunctionOct 17, 2022Mechanical Problem; Material Twisted/Bent; Mechanical Problem; Material Twisted/Bent

  IT WAS REPORTED DURING A DIAGNOSTIC AN UNSPECIFIED PROCEDURE, AND AS REPORTED, "WHEN THE NEEDLE WHEN WAS IN SCOPE, DOCTOR WAS UNABLE TO PUSH NEEDLE OUT, ONCE NEEDLE OUT OF SCOPE WAS ABLE TO PUSH NEEDLE". "USED ANOTHER NEEDLE TO COMPLETE PROCEDURE WITH NO ISSUE". THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. DEVICE EVALUATION FOUND THE NEEDLE IS BENT AND THE NEEDLE SHEATH BELOW THE METAL PROTECTOR BOOT WAS ALSO KINKED/BENT . THIS REPORT IS BEING SUBMITTED FOR BENDING OF THE NEEDLE MALFUNCTION FOUND ON DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619830 ↗
• MalfunctionOct 12, 2022Material Frayed; Material Frayed

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A BIOPSY PROCEDURE THERE WERE THREE DEVICES FROM THE SAME LOT THAT FAILED IN THE SAME MANNER. WHEN EACH OF THE FAILED DEVICES WERE INSERTED ONCE THROUGH THE WORKING CHANNEL OF A SCOPE AND A SAMPLING TAKEN, IT WAS DISCOVERED THAT THE PLASTIC PIECE BY THE END OF THE NEEDLE WHERE THE TIP COMES OUT WAS FRAYING FOR ALL OF THEM. THE PROCEDURE WAS COMPLETED WITH A FOURTH SIMILAR DEVICE FROM ANOTHER LOT. THERE IS NO ALLEGATION AGAINST THE SCOPE THAT WAS USED IN THE PROCEDURE. THE SCOPE HAD NO ISSUES IN THE PREVIOUS PROCEDURE NOR IN THE PROCEDURE THAT FOLLOWED. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587056 ↗
• MalfunctionOct 12, 2022Material Frayed; Material Frayed

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A BIOPSY PROCEDURE THERE WERE THREE DEVICES FROM THE SAME LOT THAT FAILED IN THE SAME MANNER. WHEN EACH OF THE FAILED DEVICES WERE INSERTED ONCE THROUGH THE WORKING CHANNEL OF A SCOPE AND A SAMPLING TAKEN, IT WAS DISCOVERED THAT THE PLASTIC PIECE BY THE END OF THE NEEDLE WHERE THE TIP COMES OUT WAS FRAYING FOR ALL OF THEM. THE PROCEDURE WAS COMPLETED WITH A FOURTH SIMILAR DEVICE FROM ANOTHER LOT. THERE IS NO ALLEGATION AGAINST THE SCOPE THAT WAS USED IN THE PROCEDURE. THE SCOPE HAD NO ISSUES IN THE PREVIOUS PROCEDURE NOR IN THE PROCEDURE THAT FOLLOWED. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587012 ↗
• MalfunctionOct 12, 2022Material Frayed; Material Frayed

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A BIOPSY PROCEDURE THERE WERE THREE DEVICES FROM THE SAME LOT THAT FAILED IN THE SAME MANNER. WHEN EACH OF THE FAILED DEVICES WERE INSERTED ONCE THROUGH THE WORKING CHANNEL OF A SCOPE AND A SAMPLING TAKEN, IT WAS DISCOVERED THAT THE PLASTIC PIECE BY THE END OF THE NEEDLE WHERE THE TIP COMES OUT WAS FRAYING FOR ALL OF THEM. THE PROCEDURE WAS COMPLETED WITH A FOURTH SIMILAR DEVICE FROM ANOTHER LOT. THERE IS NO ALLEGATION AGAINST THE SCOPE THAT WAS USED IN THE PROCEDURE. THE SCOPE HAD NO ISSUES IN THE PREVIOUS PROCEDURE NOR IN THE PROCEDURE THAT FOLLOWED. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586993 ↗
• MalfunctionSep 15, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A VIZISHOT NEEDLE, THE DEVICE WAS NOT VISIBLE UNDER ULTRASOUND. THE USER SWITCHED TO A DIFFERENT LOT AND FINISHED THE PROCEDURE WITH NO FURTHER DIFFICULTY. THERE WERE NO CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427555 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿THE DIAGNOSTIC YIELD OF ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) IN RESPIRATORY COMPROMISED PATIENTS UNDER GENERAL ANESTHESIA,¿ PATIENTS EXPERIENCED ADVERSE EVENTS AFTER PROCEDURES USING MULTIPLE OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE BF-UC180F USED IN THE PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE NA-201SX-4021 USED IN THE PROCEDURES. BACKGROUND: ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) IS A FREQUENTLY USED METHOD FOR OBTAINING TISSUE SAMPLES FOR THE DIAGNOSIS OF VARIOUS RESPIRATORY CONDITIONS, INCLUDING LUNG CANCER STAGING. IN MOST CASES, EBUS-TBNA IS PERFORMED UNDER MODERATE SEDATION (MS). HOWEVER, IN CASES OF RESPIRATORY COMPROMISED PATIENTS, IF THIS PROCEDURE IS PERFORMED, IT IS CONDUCTED UNDER GENERAL ANESTHESIA (GA). OBJECTIVES: TO ASSESS THE DIAGNOSTIC YIELD OF EBUS-TBNA AMONG RESPIRATORY COMPROMISED PATIENTS. METHODS: DATA OF CONSECUTIVE PATIENTS (N=191) WHO UNDERWENT EBUS-TBNA AT OUR MEDICAL CENTER BETWEEN JANUARY 2019 AND DECEMBER 2019 WERE RETROSPECTIVELY ANALYZED. RESPIRATORY COMPROMISED PATIENTS UNDERWENT GA AND PATIENTS WITHOUT

  Patient problems: Bronchospasm; Hemorrhage/Blood Loss/Bleeding; Hypoxia; Low Blood Pressure/ Hypotension

  MAUDE report 15087732 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "CONVENTIONAL TRANSBRONCHIAL NEEDLE ASPIRATION VERSUS ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION, WITH OR WITHOUT RAPID ON-SITE EVALUATION, FOR THE DIAGNOSIS OF SARCOIDOSIS: A RANDOMIZED CONTROLLED TRIAL." LITERATURE SUMMARY: THIS STUDY DESCRIBES ABOUT CONVENTIONAL TRANSBRONCHIAL NEEDLE ASPIRATION VERSUS ENDOBRONCHIAL ULTRASOUND¿GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION, WITH OR WITHOUT RAPID ON-SITE EVALUATION, FOR THE DIAGNOSIS OF SARCOIDOSIS. EIGHTY PATIENTS WITH SUSPECTED SARCOIDOSIS WERE RANDOMIZED 1:1:1:1 INTO 4 GROUPS: C-TBNA WITH OUT ROSE (TBNA-NR), C-TBNA WITH ROSE (TBNA-R), EBUS-TBNA WITHOUT ROSE (EBUS NR), AND EBUS-TBNA WITH ROSE (EBUS-R). EBB AND TBLB WERE PERFORMED IN ALL PATIENTS. FLEXIBLE BRONCHOSCOPY WAS PERFORMED THROUGH THE NASAL/ORAL ROUTE USING THE OLYMPUS BF-TE2 FIBEROPTIC BRONCHOSCOPE/OLYMPUS 1T180 VIDEO BRONCHOSCOPE. C-TBNA WAS PERFORMED FROM THE SUBCARINAL (STATION 7) AND/OR LOWER RIGHT PARATRACHEAL (4R) STATIONS USING THE 21-G TBNA NEEDLE (SMOOTH SHOT NA-401D-1521; OLYMPUS). EBUS-TBNA WAS PERFORMED THROUGH THE ORAL ROUTE UNDER MODERATE SEDATION AFTER INSERTION OF A BITE BLOCK, USING THE E

  Patient problems: Pneumothorax

  MAUDE report 15053263 ↗
• MalfunctionMar 29, 2022Mechanical Problem; Device Damaged Prior to Receipt by User; Mechanical Problem; Device Damaged Prior to Receipt by User

  CUSTOMER REPORTED THAT THE DEVICE (ASPIRATION NEEDLE DEVICE) CAME OUT OF PACKAGE BROKEN, UNABLE TO SWITCH TO SAFETY LATCH OFF TO USE THE NEEDLE. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13944681 ↗
• MalfunctionFeb 8, 2022Break; Break

  THE CUSTOMER REPORTS ON FIRST PASS ATTEMPT WITH 21G ENDOBRONCHIAL ULTRASOUND (EBUS) WITH NEEDLE IN 4R POSITION, NO PENETRATION INTO TARGET WAS ACHIEVED WITH USUAL TECHNIQUE. NO SIGNIFICANT FORCE OR COUGHING WAS NOTED. SHEATH POSITION WAS CONFIRMED PRIOR TO ATTEMPT. DURING THE SECOND ATTEMPT, A METAL PIECE (LIKELY GUIDE WIRE PROTRUDING PAST THE NOW BROKEN NEEDLE) WAS SEEN FACING THE CAMERA. THE NEEDLE DEVICE WAS REMOVED, AND METAL PIECE NOTED IN AIRWAY. THE USER SWITCHED SCOPES, AND AN APPROXIMATELY 1CM NEEDLE TIP WAS REMOVED FROM THE AIRWAY WALL. THIS RESULTED A DELAY IN THE PROCEDURE (TIME INTERVAL NOT PROVIDED). THE PROCEDURE WAS CONTINUED WITH A NEW NEEDLE AND EASY PASSES PERFORMED IN 4R POSITION AT SAME LOCATION. NO COMPLICATIONS OR ADVERSE OUTCOME NOTED FOR THE PATIENT DURING THE REMAINING TIME IN THE BRONCHOSCOPY SUITE OR IN THE RECOVERY ROOM. NO ADDITIONAL CONSEQUENCES TO THE PATIENT ARE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480998 ↗
• MalfunctionJan 14, 2022Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  OLYMPUS RECEIVED MEDWATCH REPORT #3902560000-2021-8103 WITH AN EVENT REPORTED THAT THE NEEDLE LOCK FUNCTION FAILED, PREVENTING STAFF FROM SECURING NEEDLE WHILE ENTERING AND EXITING THE AIRWAY. THE ISSUE FOUND DURING A BRONCHOSCOPY PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259332 ↗
• MalfunctionDec 2, 2021Break; Break

  AS REPORTED, NEEDLE BROKE IN THE MIDDLE OF THE GUIDE SHEATH AFTER TWO PUNCTURES. THE ISSUE FOUND DURING A DIAGNOSTIC LINEAR EBUS (ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY) PROCEDURE. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE WITH SAME MODEL AND SAME LOT NUMBER (NA-201SX-4021 LOT OZV ). THE INTENDED PROCEDURE WAS COMPLETED WITH NO INJURY OR HARM TO THE PATIENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920029 ↗
• MalfunctionNov 30, 2021Defective Device; Defective Device

  OLYMPUS RECEIVED MAUDE MDR REPORT KEY (B)(4) WITH A DEVICE ISSUE STATED "THE NEEDLE LOCK FUNCTION FAILED, PREVENTING STAFF FROM SECURING NEEDLE WHILE ENTERING AND EXITING THE AIRWAY". THERE ARE NO FURTHER DETAILS PROVIDED IN THE REPORT REGARDING THE EVENT/PROBLEM REPORTED. THERE WAS NO PATIENT HARM OR INJURY REPORTED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12902234 ↗
• MalfunctionAug 19, 2021Leak/Splash; Leak/Splash

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, DURING A THERAPEUTIC PROCEDURE, WHILE USING THE SINGLE USE ASPIRATION NEEDLE, THE BIOPSY PORT WAS LEAKING AND SPRAYING WATER. NO PATIENT INJURY REPORTED. THE SAME ISSUE OCCURRED AT THE FACILITY WITH TWO (2) SEPARATE PATIENTS ON THE SAME DAY USING A NEW SINGLE USE ASPIRATION NEEDLE. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341683 ↗
• MalfunctionAug 19, 2021Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER. THE ISSUE OCCURRED IN THE BEGINNING OF AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE. AN EBUS BRONCHOSCOPE WAS BEING USED WITH THE SINGLE USE ADAPTER BIOPSY VALVE AND SINGLE USE ASPIRATION NEEDLE. NO OTHER DEVICES WERE INVOLVED IN THE EVENT. THERE WAS NO SURGICAL DELAY. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE DEVICE WAS INSPECTED PRIOR TO USE AND APPEARED INTACT AND GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341632 ↗
• MalfunctionJun 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED, THE NEEDLE LOCKING MECHANISM ON THE SINGLE-USE ASPIRATION NEEDLE WAS LOOSE. ACCORDING TO THE INITIAL REPORTER, IT DID NOT APPEAR TO BE LOCKING IN PLACE. THIS EVENT DID OCCUR DURING A PROCEDURE; HOWEVER, NO PATIENT HARM OR CONSEQUENCE WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992233 ↗
• MalfunctionJun 2, 2021Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. THE VIZISHOT NEEDLE WAS PASSED THROUGH THE BRONCHIAL SCOPE SEVERAL TIMES AND THEN THE SURGEON NOTED THAT THE NEEDLE WAS BENT. THERE WAS NO DELAY IN THE PROCEDURE. ANOTHER NEEDLE WAS OPENED, AND THE CASE PRECEDED WITHOUT ANY ISSUES. UPON SETTING UP FOR THE CASE, NO DEFECT WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921407 ↗