Single Use Aspiration Needle NA-U200H NA-U200H-8022Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04953170380488), received between Feb 14, 2022 and Jul 21, 2025 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE SUBJECT DEVICE WAS USED AFTER THE STERILIZATION HAD EXPIRED. THERE WERE NO REPORTS OF PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556675 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿COMPARING NEEDLES AND METHODS OF ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY TO OPTIMIZE SPECIMEN QUALITY AND DIAGNOSTIC ACCURACY FOR PATIENTS WITH PANCREATIC MASSES IN A RANDOMIZED TRIAL¿. BACKGROUND & AIMS: GIVEN THE LACK OF PROCEDURE STANDARDIZATION, FINDINGS VARY FROM ANALYSES OF PANCREATIC TISSUES COLLECTED BY ENDOSCOPIC ULTRASOUND¿GUIDED FINE-NEEDLE BIOPSY. IT IS NOT CLEAR WHICH NEEDLE AND TECHNIQUE YIELD THE BEST SPECIMEN FOR ANALYSIS. WE COMPARED THE SPECIMEN QUALITY AND ACCURACY OF DIAGNOSES MADE FROM SAMPLES COLLECTED BY FINE-NEEDLE BIOPSY NEEDLES USING DIFFERENT COLLECTION TECHNIQUES. METHODS: PATIENTS FOUND TO HAVE PANCREATIC MASSES DURING IMAGING (N 129) WERE ASSIGNED RANDOMLY TO GROUPS FROM WHOM PANCREATIC TISSUE SAMPLES WERE COLLECTED BY REVERSE-BEVEL, MENGHINI-TIP, FRANSEEN, OR FORK-TIP NEEDLES. A SECOND RANDOMIZATION DETERMINED THE TECHNICAL SEQUENCE OF BIOPSIES IN EACH PATIENT (SUCTION, NO SUCTION, AND STYLET RETRACTION). TWO INDEPENDENT PATHOLOGISTS, BLINDED TO THE TYPE OF NEEDLE AND SAMPLING TECHNIQUE, ANALYZED ALL THE SAMPLES. FINAL DIAGNOSES OF MALIGNANCY WERE MADE BASED ON SURGICAL RESECTION, DEATH FROM CA

  Patient problems: Abdominal Pain; Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20847547 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿COMPARING NEEDLES AND METHODS OF ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY TO OPTIMIZE SPECIMEN QUALITY AND DIAGNOSTIC ACCURACY FOR PATIENTS WITH PANCREATIC MASSES IN A RANDOMIZED TRIAL¿. BACKGROUND & AIMS: GIVEN THE LACK OF PROCEDURE STANDARDIZATION, FINDINGS VARY FROM ANALYSES OF PANCREATIC TISSUES COLLECTED BY ENDOSCOPIC ULTRASOUND¿GUIDED FINE-NEEDLE BIOPSY. IT IS NOT CLEAR WHICH NEEDLE AND TECHNIQUE YIELD THE BEST SPECIMEN FOR ANALYSIS. WE COMPARED THE SPECIMEN QUALITY AND ACCURACY OF DIAGNOSES MADE FROM SAMPLES COLLECTED BY FINE-NEEDLE BIOPSY NEEDLES USING DIFFERENT COLLECTION TECHNIQUES. METHODS: PATIENTS FOUND TO HAVE PANCREATIC MASSES DURING IMAGING (N 129) WERE ASSIGNED RANDOMLY TO GROUPS FROM WHOM PANCREATIC TISSUE SAMPLES WERE COLLECTED BY REVERSE-BEVEL, MENGHINI-TIP, FRANSEEN, OR FORK-TIP NEEDLES. A SECOND RANDOMIZATION DETERMINED THE TECHNICAL SEQUENCE OF BIOPSIES IN EACH PATIENT (SUCTION, NO SUCTION, AND STYLET RETRACTION). TWO INDEPENDENT PATHOLOGISTS, BLINDED TO THE TYPE OF NEEDLE AND SAMPLING TECHNIQUE, ANALYZED ALL THE SAMPLES. FINAL DIAGNOSES OF MALIGNANCY WERE MADE BASED ON SURGICAL RESECTION, DEATH FROM CA

  Patient problems: Abdominal Pain; Gastrointestinal Hemorrhage; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20846590 ↗
• MalfunctionSep 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE SINGLE USE ASPIRATION NEEDLE BECAME STUCK IN THE SHEATH DURING THE FIRST EXTRACTION. THE ISSUE OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258513 ↗
• MalfunctionJul 11, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE ASPIRATION NEEDLE GUIDEWIRE WAS DIFFICULT TO INSERT AND GOT STUCK. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724703 ↗
• MalfunctionJun 28, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE WAS INSERTED INTO THE PATIENT AND WHEN THE FIELDER GUIDE WIRE SET WAS ATTEMPTED TO BE INSERTED IT GOT STUCK. THE ISSUE OCCURRED DURING A THERAPEUTIC INTERVENTIONAL ENDOSCOPIC ULTRASOUND PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634247 ↗
• MalfunctionJun 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE FELL OFF OUTSIDE OF THE PATIENT'S BODY. THE ISSUE OCCURRED DURING PREPARATION FOR USE IN A DIAGNOSTIC EUS-FNA (ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION) BIOPSY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE PATIENT WAS NOT ANESTHETIZED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19597434 ↗
• MalfunctionJun 5, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE EXHIBITED GUIDEWIRE STUCK THE ISSUE OCCURRED THERAPEUTIC ENDOSCOPIC ULTRASOUND- GUIDED BILIARY DRAINAGE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS DELAY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473518 ↗
• InjuryFeb 23, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS), WHILE USING WITH AN ULTRASOUND GASTROVIDEOSCOPE AND A SINGLE USE ASPIRATION NEEDLE, A PUNCTURE GUIDEWIRE ENTERED THE PATIENT'S BLOOD VESSEL INSTEAD OF THE TARGET BILE DUCT CAUSING A DELAY OF ABOUT 25 MINUTES. AFTER BILE DUCT DILATION AND STENT PLACEMENT, BLOOD HAD ACCUMULATED IN THE GASTROINTESTINAL TRACT. THE ULTRASOUND GASTROVIDEOSCOPE WAS IMMEDIATELY REMOVED SINCE IT COULD NOT ASPIRATE THE BLOOD AND REPLACED WITH ANOTHER SCOPE. THE PROCEDURE WAS COMPLETED THEREAFTER. THE PATIENT'S STATUS AFTER THE PROCEDURE WAS UNKNOWN. HOWEVER, IT WAS BELIEVED THAT THE PATIENT WAS GIVEN ADDITIONAL ANTIBIOTICS SINCE GUIDEWIRES USUALLY DO NOT GO INTO BLOOD VESSELS. THE PHYSICIAN REPORTEDLY ALSO NOTED THAT EVEN IF THE TARGET BILE DUCT WAS SHOWN ON THE ULTRASOUND IMAGE AND THE NEEDLE WAS TAKEN OUT, THE NEEDLE COULD NOT BE SEEN AND IF YOU TWIST AND PUT THE NEEDLE IN THE SCREEN, THE BILE DUCT WILL BE DISPLACED FROM ITS INTENDED LOCATION. FURTHER, THE TREATMENT TOOL WOULD NOT SHOW UP IN THE OPTICAL IMAGE EVEN IF YOU TAKE IT OUT AND IT WAS NOT POSSIBLE TO CAPTURE THE DESIRED BILE DUCT AND NEEDLE ON THE SAME ULTRA

  Patient problems: Gastrointestinal Hemorrhage; Perforation of Vessels

  MAUDE report 18768846 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "SAFETY AND DIAGNOSTIC YIELD OF ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY FOR HYPERVASCULAR PANCREATIC LESIONS."     ¿LITERATURE SUMMARY¿ THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE SAFETY AND DIAGNOSTIC YIELD OF ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY (EUS-FNB) FOR HYPERVASCULAR PANCREATIC SOLID LESIONS. A TOTAL OF 301 PATIENTS WERE INCLUDED. THE SENSITIVITY, SPECIFICITY, AND ACCURACY RATES OF EUS-FNB FOR HYPERVASCULAR LESIONS WERE 94.7%, 100%, AND 96.2%, AND THOSE FOR HYPOVASCULAR LESIONS WERE 80.0%, 100%, AND 84.6%, RESPECTIVELY. THERE WAS NO DIFFERENCE IN DIAGNOSTIC PERFORMANCE BETWEEN HYPERVASCULAR AND HYPOVASCULAR LESIONS.     ¿TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ 1) EVENT #1 -BLEEDING - 3 PATIENTS 2) EVENT #2 PANCREATITIS - 3 PATIENTS 3) EVENT #3 INFECTION - 1 PATIENT 4) EVENT #4 PAIN - 1 PATIENT   THE REPORT IS LINKED TO THE RELATED PATIENT IDENTIFIER (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Pancreatitis; Unspecified Infection

  MAUDE report 18691141 ↗
• MalfunctionAug 24, 2023Difficult to Insert; Difficult to Insert

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN THE GUIDE WIRE (E0018450AG-2) WAS INSERTED INTO THE SINGLE USE ASPIRATION NEEDLE, IT BECAME STUCK AND COULD NOT BE INSERTED. THE ISSUE WAS FOUND WHILE PREPARING FOR A THERAPEUTIC ENDOSCOPIC ULTRASONOGRAPHY-GUIDED BILIARY DRAINAGE PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612372 ↗
• MalfunctionJul 18, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER DURING CLINICAL USE THE SINGLE USE ASPIRATION NEEDLE DID NOT SHOW UP WELL ON ULTRASOUND. THE PROBLEM WAS RESOLVED WHEN THE SUBJECT DEVICE WAS REPLACED WITH A SIMILAR DEVICE, IT IS THOUGHT THE ASPIRATION NEEDLE WAS THE ISSUE. THE UNSPECIFIED DIAGNOSTIC PROCEDURE WAS COMPLETED USING THE REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342876 ↗
• MalfunctionMay 30, 2023Expiration Date Error; Expiration Date Error

  HOLD FOR TG 6.16 AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE ASPIRATION NEEDLE NA-U200H-8022 EXPIRES IN AUGUST 2023, BUT THE ASPIRATION SYRINGES EXPIRED ON APRIL 30, 2023. THE EVENT OCCURRED DURING MAINTENANCE. THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020022 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "FEASIBILITY OF ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY USING A 22-GAUGE NEEDLE." THIS SINGLE-CENTER RETROSPECTIVE STUDY AIMED TO EVALUATE THE FEASIBILITY OF PERFORMING ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY USING A 22-GAUGE FINE-NEEDLE ASPIRATION NEEDLE IN 14 PATIENTS. OVERALL TECHNICAL SUCCESS WAS ACHIEVED IN 11 CASES (78.6%) AND SUBSEQUENTLY, 11 CASES OF TECHNICAL SUCCESS WERE ANALYZED. CLINICAL SUCCESS WAS ACHIEVED IN ALL THE CASES. THE PROCEDURE TIME RANGED FROM 15 TO 93 MINUTES, WITH A MEDIAN DURATION OF 35 MINUTES. THIS STUDY CONCLUDES THAT EUS-HGS USING A 22-GAUGE FNA NEEDLE IS INITIALLY EFFECTIVE. HOWEVER, IN 72.7% OF THE CASES STARTED USING THE 0.018-INCH GUIDEWIRE, THE GUIDEWIRE WAS EXCHANGED FOR A 0.025-INCH GUIDEWIRE DURING PROCEDURE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: BILIARY PERITONITIS - 4 PATIENTS. BILOMA - 1 PATIENT. SINCE THE LITERATURE DESCRIBED "22G EZ SHOT 3PLUS", WE SELECTED "NA-U200H-8022" AS A REPRESENTATIVE PRODUCT. THIS MEDWATCH IS BEING SUBMITTED FOR THE NA-U200H-8022 SINGLE-USE ASPIRATION NEEDLE, WITH PATIENT IDENTIFIER (B)(6). THE SCOPE REFERENCED WITHIN THE LITERATURE, GF-UCT

  Patient problems: Peritonitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 16194862 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: EXAMINATION OF NEEDLES USED FOR EUS-FNA IN OUR HOSPITAL. [LITERATURE SUMMARY] NEEDLES USED FOR EUS-FNA ARE BEING IMPROVED DAILY, IN FNA. THERE ARE VARIOUS REPORTS ON THE SELECTION OF NEEDLES, AND IT IS DIFFICULT TO SELECT ONE FROM VARIOUS OPTIONS. THE SELECTION OF A PUNCTURE NEEDLE FOR RELIABLE SAMPLE COLLECTION NEEDS TO BE EXAMINED FROM VARIOUS POINTS OF VIEW. [TYPE OF ADVERSE EVENTS / NUMBER OF PATIENTS] THERE WERE 8 COMPLICATIONS IN TOTAL (1 CASE OF PERFORATION WITH FRANCINE NEEDLE, 1 CASE OF BLEEDING, 1 CASE OF INTRADUCTAL BLEEDING WITH FORK TIP NEEDLE, 1 CASE OF PANCREATITIS, 3 CASES OF PANCREATITIS WITH LANCET NEEDLE, 1 CASE OF BLEEDING). ONE CASE OF BLEEDING THAT REQUIRED ANGIO WAS A CASE OF SPLENIC ARTERY INJURY WHEN PUNCTURED WITH 19G. THE PRODUCT WAS UNKNOWN BUT A REPRESENTATIVE PRODUCT WAS CHOSEN FOR PROCESSING PURPOSES. (NA-U200H-) 8022).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation

  MAUDE report 14656103 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED: "A CASE OF HIGH GRADE PANCREATIC INTRAEPITHELIAL NEOPLASIA DIAGNOSED BY ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION, " THE PATIENT EXPERIENCED MILD PANCREATITIS. THIS LITERATURE IS A CASE REPORT OF HIGH GRADE PANCREATIC INTRAEPITHELIAL NEOPLASIA DIAGNOSED BY ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION (EUS-FNA). THE PATIENT WAS A (B)(6) MAN WHO CAME FOR A CHECKUP. MAIN PANCREATIC DUCT (MPD) DILATATION WAS OBSERVED ON ABDOMINAL ULTRASONOGRAPHY. HIS TUMOR MARKER LEVELS WERE NORMAL. CONTRAST-ENHANCED COMPUTED TOMOGRAPHY SHOWED A DILATED CAUDAL MPD AND PANCREATIC PARENCHYMA ATROPHY, CONSISTENT WITH THE INTERRUPTION OF THE MPD IN THE PANCREATIC BODY. MAGNETIC RESONANCE CHOLANGIOPANCREATOGRAPHY REVEALED CAUDAL MPD DILATATION AND A SMALL CYSTIC LESION AROUND THE MPD STENOSIS. ENDOSCOPIC ULTRASOUND (EUS) SHOWED A FAINT 10-MM HYPOECHOIC AREA AROUND THE PANCREATIC DUCT WITH INDISTINCT BORDERS, IRREGULAR CONTOURS, AND HETEROGENEOUS INTERNAL ECHOGENICITY. HIGH GRADE PANCREATIC INTRAEPITHELIAL NEOPLASIA OR MINIMALLY INVASIVE CARCINOMA WAS SUSPECTED. ENDOSCOPIC PANCREATOGRAPHY REVEALED A 20-MM STENOSIS IN THE MPD; ENDOSCOPIC NASOPANCREATIC

  Patient problems: Pancreatitis

  MAUDE report 13714468 ↗
• MalfunctionFeb 14, 2022Mechanical Problem; Mechanical Problem

  THE PHYSICIAN REPORTED THAT WHILE PREPARING FOR A THERAPEUTIC ENDOSCOPIC ULTRASOUND-GUIDED BILIARY DRAINAGE PROCEDURE, ALTHOUGH THE GUIDEWIRE PASSED THROUGH THE NEEDLE, IT WAS DIFFICULT TO INSERT THE GUIDEWIRE INTO THE NEEDLE, SO THE LUMEN OF THE NEEDLE MAY HAVE BEEN NARROW. THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, AFTER PUNCTURING THE TISSUE WITH THE BIOPSY NEEDLE, THE GUIDEWIRE WAS CAUGHT IN THE BIOPSY NEEDLE UPON INSERTION AND IT BECAME IMPOSSIBLE TO PULL OUT THE GUIDEWIRE. THE ENTIRE ENDOSCOPE WAS REMOVED BY PULLING THE NEEDLE AND GUIDEWIRE OUT TOGETHER, PRIOR TO REMOVING THE ENDOSCOPE. THE PROCEDURE WAS STOPPED AND SUBSEQUENTLY CANCELLED. THE PHYSICIAN NOTED THAT EVEN AFTER REMOVING THE NEEDLE AND GUIDEWIRE FROM THE ENDOSCOPE, THE GUIDEWIRE COULD NOT BE REMOVED FROM THE NEEDLE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13523551 ↗