BIOPSY FORCEPS FB-26N-1Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of BIOPSY FORCEPS (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170030116), received between Apr 27, 2022 and Apr 27, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Pancreatitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC ULTRASOUND PLUS ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY BASED TISSUE SAMPLING FOR DIAGNOSIS OF PROXIMAL AND DISTAL BILIARY STENOSIS DUE TO CHOLANGIOCARCINOMA: RESULTS FROM A RETROSPECTIVE SINGLE-CENTER STUDY." ABSTRACT: DIFFERENTIATING BETWEEN BENIGN AND MALIGNANT BILIARY STENOSIS (BS) IS CHALLENGING, WHERE TISSUE DIAGNOSIS PLAYS A CRUCIAL ROLE. ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)- BASED TISSUE SAMPLING AND ENDOSCOPIC ULTRASOUND (EUS) WITH FINE-NEEDLE ASPIRATION (FNA) OR BIOPSY (FNB) ARE USED TO OBTAIN TISSUE SPECIMENS FROM BS. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE DIAGNOSTIC YIELD OF EUS-FNA/B PLUS ERCP WITH BRUSHING OR FORCEPS BIOPSY IN BS. ALL ENDOSCOPIC PROCEDURES PERFORMED IN PATIENTS WITH BS AT OUR GASTROENTEROLOGY UNIT WERE REVIEWED. THE GOLD STANDARD FOR DIAGNOSIS WAS HISTOPATHOLOGY OF SURGICAL SPECIMENS OR THE PROGRESSION OF THE MALIGNANCY AT RADIOLOGICAL OR CLINICAL FOLLOW-UP. A TOTAL OF 70 ENDOSCOPIC PROCEDURES WERE PERFORMED IN 51 PATIENTS WITH BS. FINAL ENDOSCOPIC DIAGNOSIS WAS REACHED IN 96% OF THE PATIENTS AND WAS MALIGNANT IN 61.7% AND BENIGN IN 38.3% OF CASES. SE
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis
MAUDE report 14218898 ↗
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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