DISPOSABLE BIOPSY FORCEPSRecalls & reported problems across all models

We found 23 models of DISPOSABLE BIOPSY FORCEPS by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 130 adverse event reports in the FDA's MAUDE database, received between May 31, 2018 and Feb 27, 2026 — classified as 66 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Break” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DISPOSABLE BIOPSY FORCEPS problems

DISPOSABLE BIOPSY FORCEPS models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DISPOSABLE BIOPSY FORCEPS FB-220U

  FORCEPS, BIOPSY, NON-ELECTRIC
  32 reports
• DISPOSABLE BIOPSY FORCEPS FB-231D

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  29 reports
• DISPOSABLE BIOPSY FORCEPS FB-230U

  FORCEPS, BIOPSY, NON-ELECTRIC
  7 reports
• DISPOSABLE BIOPSY FORCEPS FB-220U

  FORCEPS, BIOPSY, NON-ELECTRIC
  5 reports
• DISPOSABLE BIOPSY FORCEPS FB-231K

  Forceps, Biopsy, Non-Electric
  5 reports
• DISPOSABLE BIOPSY FORCEPS FB-244U

  FORCEPS, BIOPSY, NON-ELECTRIC
  5 reports
• DISPOSABLE BIOPSY FORCEPS FB-210U

  FORCEPS, BIOPSY, NON-ELECTRIC
  5 reports
• DISPOSABLE BIOPSY FORCEPS FB-231D

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  5 reports
• DISPOSABLE BIOPSY FORCEPS FB-211D

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  4 reports
• DISPOSABLE BIOPSY FORCEPS FB-240U

  FORCEPS, BIOPSY, NON-ELECTRIC
  4 reports
• DISPOSABLE BIOPSY FORCEPS FB-231K

  Forceps, Biopsy, Non-Electric
  4 reports
• DISPOSABLE BIOPSY FORCEPS FB-211D

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  4 reports
• DISPOSABLE BIOPSY FORCEPS FB-241K

  Forceps, Biopsy, Non-Electric
  3 reports
• DISPOSABLE BIOPSY FORCEPS FB-230K

  FORCEPS, BIOPSY, NON-ELECTRIC
  3 reports
• DISPOSABLE BIOPSY FORCEPS FB-230U

  FORCEPS, BIOPSY, NON-ELECTRIC
  3 reports
• DISPOSABLE BIOPSY FORCEPS FB-210U

  FORCEPS, BIOPSY, NON-ELECTRIC
  2 reports
• DISPOSABLE BIOPSY FORCEPS FB-211K

  Forceps, Biopsy, Non-Electric
  2 reports
• DISPOSABLE BIOPSY FORCEPS FB-244U

  FORCEPS, BIOPSY, NON-ELECTRIC
  2 reports
• DISPOSABLE BIOPSY FORCEPS FB-211K

  Forceps, Biopsy, Non-Electric
  2 reports
• DISPOSABLE BIOPSY FORCEPS FB-210K

  FORCEPS, BIOPSY, NON-ELECTRIC
  1 report
• DISPOSABLE BIOPSY FORCEPS FB-214U

  FORCEPS, BIOPSY, NON-ELECTRIC
  1 report
• DISPOSABLE BIOPSY FORCEPS FB-224U

  FORCEPS, BIOPSY, NON-ELECTRIC
  1 report
• DISPOSABLE BIOPSY FORCEPS FB-210U

  Forceps, Biopsy, Non-Electric
  1 report

Recent DISPOSABLE BIOPSY FORCEPS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Difficult to Open or Close

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BIOPSY FORCEPS EXHIBITED FOREIGN MATTER WAS ADHERING ON THE FORCEPS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475031 ↗
• InjuryNov 14, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A COLONOSCOPY AND POLYPECTOMY, DUE TO THE INSUFFICIENT SHARPNESS OF THE BIOPSY CUP, THE MUCOSA WAS TORN, RESULTING IN BLEEDING THAT REQUIRED HEMOSTASIS WITH A CLIP. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23555189 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THERAPEUTIC COLONOSCOPY, WHEN DISPOSABLE BIOPSY FORCEPS WERE USED BLEEDING OCCURRED WHICH REQUIRED A CLIP.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23083963 ↗
• MalfunctionAug 27, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISPOSABLE BIOPSY FORCEPS EXHIBITED FOREIGN MATERIAL (FRAGMENTS) THAT FELL INTO THE STOMACH WHEN OPERATING THE BIOPSY FORCEPS IN THE STOMACH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904549 ↗
• InjuryJul 10, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A COLD BIOPSY PROCEDURE, WHILE USING DISPOSABLE BIOPSY FORCEPS, THE DEVICE DID NOT CLOSE PROPERLY. ANOTHER SET OF DISPOSABLE BIOPSY FORCEPS WERE OBTAINED, AND AN ADEQUATE TISSUE SAMPLE WAS COLLECTED. THE FORCEPS TORE THE PATIENT'S MUCOSA, AND A CLIP WAS REQUIRED TO CLOSE THE TEAR AND STOP BLEEDING. THE PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT WAS DISCHARGED AND ADVISED OF THE CLIP WITH INSTRUCTIONS ON IDENTIFYING SIGNS OF BLEEDING.

  Patient problems: Gastrointestinal Hemorrhage; Laceration(s)

  MAUDE report 22475295 ↗
• InjuryJun 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE; WHILE USING THE BRONCHO VIDEOSCOPE ALONG WITH A SINGLE-USE BIOPSY VALVE, A PIECE OF THE BIOPSY VALVE FELL OFF INTO THE PATIENT¿S BODY WHEN THE BIOPSY FORCEPS WERE INSERTED INTO THE SCOPE AND REACHED THE DISTAL END OF THE SCOPE. AFTER THE PROCEDURE, INSPECTION OF THE BIOPSY VALVE REVEALED THAT THE SEAL RING INSIDE THE BIOPSY VALVE WAS CHIPPED. IT IS SUSPECTED THAT THE SEAL RING MAY HAVE FALLEN INTO THE PATIENT¿S BODY. WHILE ATTEMPTING TO RETRIEVE THE FALLEN OBJECT, THE PATIENT BEGAN COUGHING, AND THE OBJECT WAS LOST FROM VIEW. THE FALLEN OBJECT WAS NOT RETRIEVED. IT WAS UNCLEAR WHETHER THE OBJECT REMAINED IN THE LUNG OR THE STOMACH. ACCORDING TO THE PHYSICIAN, IT IS LIKELY THAT THE OBJECT WAS EXPELLED TOWARD THE STOMACH AS A RESULT OF THE COUGHING. A LUNG EXAMINATION WAS PERFORMED, BUT THE FALLEN OBJECT COULD NOT BE FOUND. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT DIAGNOSTIC IMAGING WAS USED AND THE PATIENT WAS UNDER SEDATION DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITH A DELAY OF MORE THAN 30 MINUTES. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22324205 ↗
• MalfunctionJun 16, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISPOSABLE BIOPSY FORCEPS EXHIBITED A FOREIGN SUBSTANCE ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214849 ↗
• MalfunctionMay 20, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISPOSABLE BIOPSY FORCEPS EXHIBITED FOREIGN MATERIAL ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054211 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ULTRATHIN BRONCHOSCOPY WITHOUT VIRTUAL NAVIGATION FOR DIAGNOSIS OF PERIPHERAL LUNG LESIONS" LITERATURE SUMMARY: BACKGROUND: THE INCREASING INCIDENCE OF ENCOUNTERING LUNG NODULES NECESSITATES AN ONGOING SEARCH FOR IMPROVED DIAGNOSTIC PROCEDURES. VARIOUS BRONCHOSCOPIC TECHNOLOGIES HAVE BEEN INTRODUCED OR ARE IN DEVELOPMENT, BUT FURTHER STUDIES ARE NEEDED TO DEFINE A METHOD THAT FITS BEST IN CLINICAL PRACTICE AND HEALTH CARE SYSTEMS. RESEARCH QUESTION HOW DO BASIC BRONCHOSCOPIC TOOLS INCLUDING A COMBINATION OF THIN (OUTER DIAMETER 4.2 MM) AND ULTRATHIN BRONCHOSCOPES (OUTER DIAMETER 3.0 MM), RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) AND FLUOROSCOPY PERFORM IN PERIPHERAL PULMONARY LESION DIAGNOSIS? STUDY DESIGN AND METHODS: THIS IS A RETROSPECTIVE REVIEW OF THE PERFORMANCE OF PERIPHERAL BRONCHOSCOPY USING THIN AND ULTRATHIN BRONCHOSCOPY WITH REBUS AND 2D FLUOROSCOPY WITHOUT A NAVIGATIONAL SYSTEM FOR EVALUATING PERIPHERAL LUNG LESIONS IN A SINGLE ACADEMIC MEDICAL CENTER FROM 11/2015 TO 1/2021. WE USED A STRICT DEFINITION FOR DIAGNOSTIC YIELD AND ASSESSED THE IMPACT OF DIFFERENT VARIABLES ON DIAGNOSTIC YIELD, SPECIFICALLY AF

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 20705628 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE AUTHOR NOTED THAT ULTRATHIN SCOPE INCREASED THE DIAGNOSTIC YIELD IN ADDITION TO THE THIN SCOPE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 20705605 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "BRONCHIAL BRANCH TRACING NAVIGATION IN ULTRATHIN BRONCHOSCOPY-GUIDED RADIAL ENDOBRONCHIAL ULTRASOUND FOR PERIPHERAL PULMONARY NODULE." LITERATURE SUMMARY: THIS STUDY AIMED TO DESCRIBE THE PERFORMANCE OF BRONCHIAL BRANCH TRACING (BBT) AS THE SOLE NAVIGATION METHOD IN NAVIGATING ULTRATHIN BRONCHOSCOPE RADIAL ENDOBRONCHIAL ULTRASOUND (UTB-REBUS) PROCEDURES FOR PATIENTS WITH SMALL PERIPHERAL PULMONARY LESIONS (PPLS) BY ASSESSING BOTH THE NAVIGATION SUCCESS AND THE DIAGNOSTIC YIELD. A TOTAL OF 47 PATIENTS WITH A MEAN AGE OF 61.6 (SD 9.53) YEARS WERE INVOLVED IN THIS STUDY. THE MEDIAN PROCEDURE TIME FROM THE INITIATION OF ANAESTHESIA TO THE CONCLUSION OF THE PROCEDURE WAS 40.0 (IQR 30.0¿45.0) MINUTES. THE NAVIGATION SUCCESS USING BBT NAVIGATION WAS 91.5%. THE INDEX DIAGNOSTIC YIELD WAS 82.9%, AND AT 12 MONTHS OF FOLLOW-UP, THE FINAL DIAGNOSTIC YIELD INCREASED TO 91.5%. THE OVERALL DIAGNOSTIC YIELD FOR FORCEPS BIOPSY WAS 84.6% AND 94.1% FOR CRYOBIOPSY, P>0.05. IN CONCENTRIC-ORIENTED REBUS LESIONS, BOTH FORCEPS AND CRYOBIOPSY ACHIEVED A 100% DIAGNOSTIC YIELD. THE DIRECT BRONCHUS SIGN WAS THE ONLY FACTOR ASSOCIATED WITH A BETTER FINAL DIAGNO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 20598961 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED "SAFETY AND RISK FACTORS FOR BLEEDING COMPLICATIONS OF RADIAL PROBE ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL BIOPSY." THIS STUDY AIMED TO EVALUATE THE DIAGNOSTIC PERFORMANCE AND COMPLICATION RATE OF RADIAL EBUS-GUIDED TRANSBRONCHIAL BIOPSY (TBB) AND INVESTIGATE RISK FACTORS ASSOCIATED WITH PROCEDURE-RELATED BLEEDING EVENTS. OF 133 PATIENTS (MEDIAN AGE, 69 YEARS; MEN 57.1%) INCLUDED, 41 WERE OUTPATIENTS (30.8%). THE MEDIAN PROCEDURE TIME WAS 22MIN (IQR, 15¿31MIN). THE DIAGNOSTIC ACCURACY, SENSITIVITY, AND SPECIFICITY FOR MALIGNANCY WERE 76.1%, 71.1%, AND 100%, RESPECTIVELY. WHEN THE 26 PATIENTS WHO DID NOT UNDERGO TBB WERE INCLUDED, THE DIAGNOSTIC ACCURACY FOR MALIGNANCY WAS 67.2%. ¿TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ EVENT1: BLEEDING (GRADE 2 OR HIGHER) (N=21). OF 21 PATIENTS (15.8%) WITH PROCEDURE-RELATED BLEEDING EVENTS, 18 HAD DELPHI GRADE 2 BLEEDING EVENTS, AND ONLY 3 HAD DELPHI GRADE 3 BLEEDING EVENTS. EPINEPHRINE WAS USED IN 19 PATIENTS, AND A BALLOON BLOCKER WAS USED IN ONE OF THEM FOR BLEEDING CONTROL. EVENT2: PNEUMONIA (N=5). NO TREATMENT INFORMATION WAS PROVIDED. EVENT3: PNEUMOTHORAX (N=3). TWO OF THE THREE PATIENTS REQU

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pleural Effusion; Pneumonia; Pneumothorax

  MAUDE report 20456568 ↗
• MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THE CABLE OF THE DISPOSABLE BIOPSY FORCEPS HEAD CAME LOOSE AND WAS REMOVED. THE ISSUE OCCURRED DURING A DIAGNOSTIC UPPER GASTROINTESTINAL ENDOSCOPY. THE PROCEDURE WAS NOT COMPLETED AS IT HAD BEEN CANCELLED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20337059 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DISPOSABLE BIOPSY FORCEPS PARTS BROKE OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087554 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISPOSABLE BIOPSY FORCEPS EXHIBITED FORCEPS PARTS BROKE OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079788 ↗

Other Olympus Medical Systems Corp. products

• EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
• EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
• EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports