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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170380525), received between May 31, 2022 and Dec 11, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FACTORS AFFECTING THE LEARNING CURVE IN THE ENDOSCOPIC ULTRASOUND-GUIDED SAMPLING OF SOLID PANCREATIC LESIONS: A PROSPECTIVE STUDY" LITERATURE SUMMARY BACKGROUND/AIMS: ENDOSONOGRAPHY IS ASSOCIATED WITH A LONG LEARNING CURVE. WE AIMED TO ASSESS VARIABLES THAT MAY INFLUENCE THE DIAGNOSTIC OUTCOMES IN ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION/BIOPSY (EUS-FNA/B) OF SOLID PANCREATIC TUMORS REGARDING THE LEVEL OF ENDOSCOPISTS' EXPERIENCE. METHODS: CONSECUTIVE PATIENTS UNDERGOING EUS-GUIDED PUNCTURE OF SOLID PANCREATIC TUMORS (EIGHT ENDOSONOGRAPHERS, INCLUDING SIX TRAINEES) WERE PROSPECTIVELY ENROLLED. AN EXPERIENCED ENDOSONOGRAPHER WAS DEFINED AS HAVING PERFORMED AT LEAST 250 EUS EXAMINATIONS, INCLUDING 75 FNA/BS. THE FINAL DIAGNOSIS WAS DETERMINED BY CYTOPATHOLOGY, HISTOPATHOLOGY, OR CLINICAL FOLLOW-UP. RESULTS: IN TOTAL, 283 EUS-FNA/BS OF SOLID PANCREATIC TUMORS (75.6% MALIGNANT) IN 239 PATIENTS (MEDIAN AGE 69 YEARS, 57.6% MALES) WERE ENROLLED. TRAINEES PERFORMED 149/283 (52.7%) OF THE INTERVENTIONS. ACCURACY AND SENSITIVITY FOR DETECTING MALIGNANCY WERE SIGNIFICANTLY HIGHER IN THE EXPERT GROUP THAN IN THE TRAINEE GROUP (85.8%

  Patient problems: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding; Hypoxia; Muscle Hypotonia; Pancreatitis; Unspecified Tissue Injury

  MAUDE report 18301195 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE "CASE REPORT TRANSJEJUNAL ENDOSCOPIC ULTRASOUND-GUIDED PANCREATIC DRAINAGE FOR PANCREATIC JEJUNOSTOMY STRICTURE USING A FORWARD-VIEWING ECHOENDOSCOPE IN A PATIENT WITH ALTERED ANATOMY."     LITERATURE SUMMARY: PANCREATIC JEJUNOSTOMY STRICTURE (PJS) IS ONE OF THE MAJOR LATE COMPLICATIONS AFTER PANCREATICODUODENECTOMY. ENDOSCOPIC ULTRASOUND-GUIDED PANCREATIC DRAINAGE (EUS-PD) IS CONSIDERED A SALVAGE TREATMENT FOR SYMPTOMATIC PJS AFTER ENDOSCOPIC RETROGRADE PANCREATOGRAPHY FAILURE; HOWEVER, THE TECHNICAL SUCCESS RATE OF THE ENDOSCOPIC TREATMENT OF PJS REMAINS UNSATISFACTORY, MAINLY DUE TO SURGICALLY ALTERED ANATOMY. HEREIN, WE DESCRIBE A CASE OF PJS SUCCESSFULLY TREATED WITH TRANSJEJUNAL EUS-PD USING A FORWARD-VIEWING ECHOENDOSCOPE. A (B)(6) MAN WHO SUFFERED FROM REPETITIVE SEVERE BACK PAIN DUE TO PJS WAS REFERRED TO OUR HOSPITAL. SINCE TRANSGASTRIC EUS-PD WAS DIFFICULT, WE ATTEMPTED TRANSJEJUNAL EUS-PD USING A FORWARD-VIEWING ECHOENDOSCOPE. TO FACILITATE SCOPE INSERTION, WE FIRST STRAIGHTENED THE AFFERENT JEJUNA! LOOP AND PLACED A STIFF GUIDEWIRE. WITH THIS SCHEME, WE SUCCESSFULLY PERFORMED TRANSJEJUNAL EUS-PD AND PLACED A 5-FR PLASTIC STENT.

  Patient problems: Pancreatitis

  MAUDE report 14548280 ↗