Flexision 490104Recalls & reported problems
Intuitive Surgical, Inc. · Biopsy Needle, 19G · Class 2
All models of Flexision (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886874115978), received between Jul 22, 2021 and Sep 7, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Integrity Problem1
- Patient Device Interaction Problem1
- Retraction Problem1
- Unintended Movement1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Pneumothorax1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2024Material Integrity Problem; Material Integrity Problem
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 20164709 ↗InjuryDec 3, 2021Retraction Problem; Unintended Movement; Patient Device Interaction Problem; Retraction Problem; Unintended Movement; Patient Device Interaction Problem
InjuryJul 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE WAS "CAUGHT" UPON REMOVAL AND THE TIP OF THE SHEATH BROKE OFF DUE TO THIS RESISTANCE. THE FRAGMENT FELL INSIDE THE PATIENT, BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) RECEIVED IMAGES OF THE BIOPSY NEEDLE. A REVIEW OF THE IMAGES CONFIRMED THAT THE RADIOPAQUE SHEATH TIP WAS THE PART THAT WAS BROKEN. ISI HAS CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL DETAILS RELATED TO THE EVENT. HOWEVER, AS OF THE DATE OF HIS REPORT, NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12214444 ↗
Other Bronchoscope (flexible or rigid) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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