BIOPSY FORCEPS FB-19C-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170029585), received between Aug 11, 2021 and Dec 6, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2022Device Contamination with Chemical or Other Material; Failure to Clean Adequately; Device Contamination with Chemical or Other Material; Failure to Clean Adequately

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION: THE INTENDED PROCEDURE WAS A THERAPEUTIC ONE FOR THE REMOVAL OF FISH BONES. THERE WAS NO PATIENT HARM. THE DELAY IN THE PROCEDURE TOOK ABOUT FIVE MINUTES TO CHANGE THE FORCEPS. IT IS UNKNOWN THE EXTENT OF SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928615 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "DIFFERENTIATING TUBERCULOSIS FROM SARCOIDOSIS BY SONOGRAPHIC CHARACTERISTICS OF LYMPH NODES ON ENDOBRONCHIAL ULTRASONOGRAPHY: A STUDY OF 165 PATIENTS." THIS RETROSPECTIVE STUDY DESCRIBES ABOUT DIFFERENTIATING TUBERCULOSIS FROM SARCOIDOSIS BY SONOGRAPHIC CHARACTERISTICS OF LYMPH NODES ON ENDOBRONCHIAL ULTRASONOGRAPHY. DURING THE STUDY PERIOD, 249 EBUS-GUIDED TBNA PROCEDURES WERE PERFORMED AND A DIAGNOSIS OF SARCOIDOSIS (N= 118) OR TUBERCULOSIS (N= 47) WAS MADE IN 165 PATIENTS. THE CONVEX PROBE EBUS SCOPE (BF-UC 180F, OLYMPUS MEDICAL SYSTEMS, JAPAN) WITH A 7.5 MHZ CONVEX TRANSDUCER AND A COMPATIBLE ENDOSCOPIC ULTRASOUND SCANNER (EU-ME1, OLYMPUS MEDICAL SYSTEMS, JAPAN) WERE USED. EBUS TBNA WAS PERFORMED IN A STANDARD FASHION IN THE SUPINE POSITION BY THE ORAL ROUTE USING A DEDICATED, DISPOSABLE, 21-GAUGE, VIZISHOT NEEDLE (NA-201SX-4021, OLYMPUS MEDICAL SYSTEMS, JAPAN) UNDER REAL-TIME SONOGRAPHIC AND ENDOSCOPIC VISUALIZATION. A CONVENTIONAL FIBER OPTIC BRONCHOSCOPE (BF-1T20 OR BF-TE2, OLYMPUS, JAPAN; FB-19TV, PENTAX, JAPAN) ALONG WITH STANDARD BIOPSY FORCEPS (FB19C, OLYMPUS, JAPAN) WERE USED TO PERFORM THE BIOPSIES. A TOTAL OF 358 LYMPH

  Patient problems: Pneumothorax

  MAUDE report 15028363 ↗
• MalfunctionApr 26, 2022Contamination; Mechanical Jam; Contamination; Mechanical Jam

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING PRE-USE INSPECTION, THE DEVICE CUP DID NOT OPEN. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT. ANOTHER DEVICE WAS USED FOR THE INTENDED PROCEDURE. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE WAS FOREIGN MATERIAL ADHERING TO THE LINK MECHANISM OF THE DEVICE. THIS WAS PREVENTING THE CUP FROM OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209271 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER 22, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "COMPARISON OF EUS AND ERCP-GUIDED TISSUE SAMPLING IN SUSPECTED BILIARY STRICTURE". THE PURPOSE OF THIS LITERATURE WAS TO COMPARE THE DIAGNOSTIC YIELD OF ENDOSCOPIC ULTRASOUND(EUS) AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP)-BASED TISSUE SAMPLING IN BILIARY STRICTURES NOT ACCOMPANIED BY MASS IN ADJACENT ORGANS. IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; DEMOGRAPHIC AND CLINICAL CHARACTERISTICS FOR THE 85 PATIENTS ANALYZED IN THE STUDY. STRICTURE ALONE WAS OBSERVED IN 77.6% (66/85) OF PATIENTS AND STRICTURE ACCOMPANYING MASS WITHIN THE BILE DUCT WAS IDENTIFIED IN 19 (22.4%) PATIENTS ON CT AND/OR MRI. FOR ERCP, A DUODENOSCOPE (TJF-260; OLYMPUS) WAS USED. AFTER CANNULATION AND CHOLANGIOGRAPHY, SPHINCTEROTOMY OR BALLOON DILATATION WAS PERFORMED IN MOST CASES. THE BRUSH (RX CYTOLOGY BRUSH WIREGUIDED CYTOLOGY BRUSH, BOSTON SCIENTIFIC) WAS INSERTED INTO THE BILE DUCT OVER THE GUIDEWIRE (0.025- OR 0.035-INCH VISIGLIDE; OLYMPUS). BRUSHING CYTOLOGY WAS OBTAINED WITH MORE THAN 10 TO-AND-FRO BRUSHING STROKES PASSING THE BILIARY STRICTURE. THE BRUSH WAS SMEARED ONTO THE SLIDE, WHICH WAS FI

  Patient problems: Pancreatitis

  MAUDE report 12826215 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE LITERATURE TITLED: "TRANSBRONCHIAL BIOPSY AND CRYOBIOPSY IN THE DIAGNOSIS OF HYPERSENSITIVITY PNEUMONITIS AMONG PATIENTS WITH INTERSTITIAL LUNG DISEASE", IT IS REPORTED SIX PERCENT OF THE PATIENTS UNDERGOING A TRANSBRONCHIAL FORCEPS LUNG BIOPSY (TBBX) EXPERIENCED PNEUMOTHORAX REQUIRING CHEST TUBE PLACEMENT, AND 34.2% OF PATIENTS EXPERIENCED MODERATE BLEEDING (NO INFORMATION ABOUT TREATMENT PROVIDED). THIS SYSTEMATIC REVIEW AND META-ANALYSIS WAS PERFORMED TO ASSESS THE EFFICACY AS DIAGNOSTIC YIELD AND SAFETY AS THE COMPLICATION RATES OF TWO DIFFERENT SAMPLING TECHNIQUES VIZ., TRANSBRONCHIAL FORCEPS LUNG BIOPSY (TBBX) AND TRANSBRONCHIAL LUNG CRYOBIOPSY (TBLC) IN THE DIAGNOSIS OF HYPERSENSITIVITY PNEUMONITIS (HP) WITH INTERSTITIAL LUNG DISEASE (ILD). THROUGHOUT THE OCTOBER 2019 MEDLINE, EMBASE AND THE COCHRANE LIBRARY WERE SEARCHED AND INCLUDED THE STUDIES THAT ENROLLED PATIENTS WITH ILD AND REPORTED THE DIAGNOSTIC YIELDS AND COMPLICATION RATES FOR TBBX OR TBLC. A META-ANALYSIS OF THE DATA EXTRACTED FROM THE INCLUDED ARTICLES SHOWED BOTH TBLC AND TBBX WAS COMPLICATED BY PNEUMOTHORAX, MILD TO MODERATE AND SEVERE BLEEDING EVENTS. HOWEVER, STUDY CONCLUDED TBLC WAS FOUND TO BE MORE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 12306605 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem

  IN THE LITERATURE TITLED: "TRANSBRONCHIAL BIOPSY AND CRYOBIOPSY IN THE DIAGNOSIS OF HYPERSENSITIVITY PNEUMONITIS AMONG PATIENTS WITH INTERSTITIAL LUNG DISEASE", IT IS REPORTED SIX PERCENT OF THE PATIENTS UNDERGOING A TRANSBRONCHIAL FORCEPS LUNG BIOPSY (TBBX) EXPERIENCED PNEUMOTHORAX REQUIRING CHEST TUBE PLACEMENT, AND 34.2% OF PATIENTS EXPERIENCED MODERATE BLEEDING (NO INFORMATION ABOUT TREATMENT PROVIDED). THIS SYSTEMATIC REVIEW AND META-ANALYSIS WAS PERFORMED TO ASSESS THE EFFICACY AS DIAGNOSTIC YIELD AND SAFETY AS THE COMPLICATION RATES OF TWO DIFFERENT SAMPLING TECHNIQUES VIZ., TRANSBRONCHIAL FORCEPS LUNG BIOPSY (TBBX) AND TRANSBRONCHIAL LUNG CRYOBIOPSY (TBLC) IN THE DIAGNOSIS OF HYPERSENSITIVITY PNEUMONITIS (HP) WITH INTERSTITIAL LUNG DISEASE (ILD). THROUGHOUT THE OCTOBER 2019 MEDLINE, EMBASE AND THE COCHRANE LIBRARY WERE SEARCHED AND INCLUDED THE STUDIES THAT ENROLLED PATIENTS WITH ILD AND REPORTED THE DIAGNOSTIC YIELDS AND COMPLICATION RATES FOR TBBX OR TBLC. A META-ANALYSIS OF THE DATA EXTRACTED FROM THE INCLUDED ARTICLES SHOWED BOTH TBLC AND TBBX WAS COMPLICATED BY PNEUMOTHORAX, MILD TO MODERATE AND SEVERE BLEEDING EVENTS. HOWEVER, STUDY CONCLUDED TBLC WAS FOUND TO BE MORE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 12306588 ↗