Flexision 490102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00886874115954), received between Jan 21, 2022 and May 20, 2025 — classified as 2 injuries, 6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Unintended System Motion; Material Twisted/Bent; Unintended System Motion; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A BIOPSY NEEDLE HAD A FRICTION ISSUE. THE PROCEDURE WAS COMPLETED. NO REPORTED KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057592 ↗
• MalfunctionMay 12, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE CUSTOMER STATED THAT THE BIOPSY NEEDLE INSTRUMENT WAS NOTED TO HAVE FRICTION ISSUE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007205 ↗
• InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE PHYSICIAN DID NOT HAVE ACCESS TO A LINEAR ENDO-BRONCHIAL ULTRASOUND (EBUS) SCOPE, SO USED THE ION FOR A MEDIASTINAL STAGING OF A 4R NODE (RIGHT LOWER PARATRACHEAL LYMPH NODE). AFTER THE BIOPSY, IT WAS SEEN WITH THE CAMERA THAT PART OF THE NEEDLE BROKE OFF AND WAS LODGED INTO THE ENDOTRACHEAL (ET) TUBE. AFTER EXTUBATING, THE PART OF THE NEEDLE WAS STILL IN THE TUBE. THERE WAS NO DELAY. THE PHYSICIAN WAS WELL AWARE THAT ION WAS NOT FOR STAGING. THE DIAGNOSTIC PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE MANAGER OF CLINICAL APPLICATIONS ENGINEERING: THE MEDICAL PERSONNEL STATED THAT THEY THREW THE ET TUBE WITH THE FRAGMENT AWAY AND DID AN AIRWAY SURVEY AFTER AND DID NOT SEE ANY OTHER FRAGMENTS IN THE AIRWAY. THE PATIENT WAS DOING WELL IN RECOVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20447154 ↗
• MalfunctionNov 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE NEEDLE BIOPSY BROKE. ALL PIECES ARE THERE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18128343 ↗
• MalfunctionMay 26, 2023Unintended Movement

  NEEDLE SHEATH THROUGH SIDE WALL, SHEATH MOVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 17009780 ↗
• MalfunctionMay 1, 2023Failure to Obtain Sample; Activation Problem

  THE NEEDLE FOR NEEDLE ASPIRATION BIOPSIES WOULD NOT EXTEND FULLY FROM THE SHEATH AND WERE UNABLE TO BE USED TO RETRIEVE BIOPSIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843303 ↗
• MalfunctionOct 28, 2022Retraction Problem

  DURING BRONCHOSCOPY WHILE ATTEMPTING TO OBTAIN A NEEDLE ASPIRATION BIOPSY, THE DEVICE MALFUNCTIONED. AFTER THE THIRD PASS, THE NEEDLE BECAME UNABLE TO RETRACT CORRECTLY. THE DEVICE WAS TAKEN OUT OF SERVICE AT THAT TIME AND REPLACED WITH A NEW NEEDLE IN ORDER TO COMPLETE THE PROCESS.

  Patient problems: Insufficient Information

  MAUDE report 15690247 ↗
• InjuryJan 21, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE THE 23G FLEXISION BIOPSY NEEDLE SHEATH MOVED SIGNIFICANTLY DURING THE FIRST PASS MADE WITH IT. ON (B)(6) 2022, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE PHYSICIAN OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE PNEUMOTHORAX WAS IDENTIFIED SONOGRAPHICALLY (ULTRASOUND) AFTER THE ION PROCEDURE WAS COMPLETED. THE PHYSICIAN REPORTED THAT THEY BELIEVE THE 23G FLEXISION BIOPSY NEEDLE CONTRIBUTED TO THE PNEUMOTHORAX, BUT THAT THE BIOPSY NEEDLE WAS DISCARDED AND THEREFORE CANNOT BE RETURNED. THE PHYSICIAN CONFIRMED THAT 23G FLEXISION BIOPSY NEEDLE SHEATH MOVEMENT OCCURRED DURING THIS PROCEDURE AND THEY SAID THE MOVEMENT MAY HAVE POSSIBLY CAUSED OR CONTRIBUTED TO THE PNEUMOTHORAX. WHEN ASKED IF THE PHYSICIAN BELIEVES THIS PNEUMOTHORAX WOULD HAVE LIKELY OCCURRED VIA ANOTHER BIOPSY MODALITY, THE PHYSICIAN ANSWERED: ¿CAN¿T ANSWER THIS.¿ THE PHYSICIAN REPORTED THAT THE PNEUMOTHORAX WAS MODERATE IN SIZE, AND WAS PROBABLY A ONETIME LEAK THAT, ONCE IT WAS DRAINED COMPLETELY, DID NOT RECOLLECT. THE PATIENT EXPERIENCED CHEST PAIN AND HYPOXIC RESPIRATORY FAILURE. WHEN ASKED IF THE PATIENT WAS EVER

  Patient problems: Pneumothorax

  MAUDE report 13322743 ↗