Single Use Aspiration Needle NA NA-401D-1321Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170196669), received between Jan 31, 2023 and Jun 7, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (1 report).

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.

• MalfunctionJun 7, 2023Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE SINGLE USE ASPIRATION NEEDLE WAS BEING USED TO OBTAIN AN ENDOBRONCHIAL BIOPSY, AND AS THE NEEDLE WAS BEING PUSHED OUT OF THE SHEATH IT BENT AND CAME OUT OF SHEATH TO THE SIDE INSTEAD OF THE NEEDLE COMING OUT OF THE SHEATH STRAIGHT. THE NEEDLE TORE THE SHEATH. ANOTHER SIMILAR NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS NOTED TO BE BRONCHOSCOPY WITH ENDOBRONCHIAL ULTRASOUND. THERE WAS NO HARM TO THE PATIENT SINCE THE NEEDLE AND SHEATH WERE OUTSIDE OF THE BRONCHOSCOPE AND AWAY FROM THE PATIENT, AND THERE WAS NO HARM TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079948 ↗
• MalfunctionJan 31, 2023Mechanical Problem; Material Twisted/Bent; Mechanical Problem; Material Twisted/Bent

  OLYMPUS RECEIVED A MEDWATCH REPORT FROM THE USER FACILITY REPORTED THAT THE "NEEDLE BENT AND BROKE THROUGH THE SHEATH". ACCORDING TO THE REPORT, NEEDLE WAS BEING USED TO OBTAIN ENDOBRONCHIAL BIOPSY, THE USER PUSHED THE NEEDLE OUT FROM THE NEEDLE SHEATH AS DESIGNED. HOWEVER, AS THE NEEDLE WAS BEING PUSHED OUT OF THE SHEATH IT BENT AND CAME OUT OF SHEATH TO THE SIDE INSTEAD OF THE NEEDLE COMING OUT OF THE SHEATH STRAIGHT. THE NEEDLE TORE THE SHEATH. DID NOT PUNCTURE THE INTERNAL WORKING CHANNEL OF BRONCHOSCOPE. NO HARM TO THE PATIENT SINCE THE NEEDLE AND SHEATH HAD NOT COME IN CONTACT WITH THE PATIENT'S AIRWAY DUE TO THE BRONCHOSCOPE POSITION AT THE TIME OF THE INCIDENT. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE (DIAGNOSTIC BRONCHOSCOPY WITH ENDOBRONCHIAL ULTRASOUND) WAS COMPLETED USING A SMALLER SIZE BIOPSY NEEDLE. THE PROCEDURE DURATION PROLONGED ABOUT TEN (10) MINUTES WHILE THE RESPIRATORY THERAPIST REMOVED AND OBTAINED A DIFFERENT BIOPSY NEEDLE. PATIENT WAS NOT UNDER ANESTHESIA AT THE TIME OF THE INCIDENT. PROVIDER CHECKED FOR ANY BLEEDING OR AIRWAY DAMAGE AND DID NOT FIND ANY. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273643 ↗