DISPOSABLE BIOPSY FORCEPS FB-231D (UDI 04953170158209)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04953170158209), received between Dec 25, 2019 and Jun 24, 2025 — classified as 15 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 27, 2024Break; Break

  CORRECTION TO B5: IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BIOPSY FORCEPS EXHIBITED THE JAW/COMPONENT OF THE FORCEPS FALLS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076857 ↗
• MalfunctionAug 22, 2024Break; Break

  CORRECTION TO B5: IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BIOPSY FORCEPS EXHIBITED THE JAW/COMPONENT OF THE FORCEPS FALLS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035493 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE WIRE CONNECTED TO THE HANDLE OF THE FORCEPS BROKE OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688499 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE DISPOSABLE BIOPSY FORCEPS EXHIBITED THE TIP OF TWO OPERATING WIRES WERE BROKEN AND THERE WERE MISSING PARTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629811 ↗
• MalfunctionApr 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISPOSABLE BIOPSY FORCEPS EXHIBITED PARTS THAT HAD FALLEN INSIDE THE BODY AND A BROKEN WIRE CONNECTED TO THE HANDLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19150042 ↗
• MalfunctionDec 28, 2023Break; Component Missing; Break; Component Missing

  THE CUSTOMER REPORTED TO OLYMPUS, THE DISPOSABLE BIOPSY FORCEPS WERE ATTEMPTED TO BE USED AND THE TIP CUP DID NOT OPEN. THE ISSUE WAS FOUND DURING AN UNKNOWN DIAGNOSTIC PROCEDURE. THE CUSTOMER ATTEMPTED TO USE A SECOND DISPOSABLE BIOPSY FORCEPS, BUT HAD THE SAME PROBLEM, AND THE PROCEDURE WAS COMPLETED USING A THIRD DISPOSABLE BIOPSY FORCEPS. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT TWO OPERATING WIRES WERE BROKEN AND THERE WERE MISSING PARTS. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409530 ↗
• MalfunctionDec 28, 2023Break; Component Missing; Break; Component Missing

  THE CUSTOMER REPORTED TO OLYMPUS, THE DISPOSABLE BIOPSY FORCEPS WERE ATTEMPTED TO BE USED AND THE TIP CUP DID NOT OPEN. THE ISSUE WAS FOUND DURING AN UNKNOWN DIAGNOSTIC PROCEDURE. THE CUSTOMER ATTEMPTED TO USE A SECOND DISPOSABLE BIOPSY FORCEPS, BUT HAD THE SAME PROBLEM, AND THE PROCEDURE WAS COMPLETED USING A THIRD DISPOSABLE BIOPSY FORCEPS. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT TWO OPERATING WIRES WERE BROKEN AND THERE WERE MISSING PARTS. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409339 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "WHEN PULMONOLOGISTS ARE NOVICE TO NAVIGATIONAL BRONCHOSCOPY, WHAT PREDICTS DIAGNOSTIC YIELD?". LITERATURE SUMMARY PREDICTING FACTORS OF DIAGNOSTIC YIELD IN ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) HAVE BEEN EXPLORED IN A NUMBER OF PREVIOUS STUDIES BASED ON DATA FROM EXPERIENCED OPERATORS. HOWEVER, LITTLE IS KNOWN ABOUT PREDICTING FACTORS WHEN THE PROCEDURE IS CARRIED OUT BY OPERATORS IN THE BEGINNING OF THEIR LEARNING CURVE. WE HERE AIM TO IDENTIFY THE ROLE OF OPERATORS¿ EXPERIENCE AS WELL AS LESION AND PROCEDURE CHARACTERISTICS ON DIAGNOSTIC YIELD OF ENB PROCEDURES IN THE HANDS OF NOVICE ENB OPERATORS. FOUR OPERATORS FROM THREE CENTERS WITHOUT PRIOR ENB EXPERIENCE WERE ENROLLED. THE OUTCOME OF CONSECUTIVE ENB PROCEDURES WAS ASSESSED AND CLASSIFIED AS EITHER DIAGNOSTIC OR NON-DIAGNOSTIC AND PREDICTING FACTORS OF DIAGNOSTIC YIELD WERE ASSESSED. A TOTAL OF 215 PROCEDURES WERE ASSESSED. A TOTAL OF 122 (57%) OF THE ENB PROCEDURES RESULTED IN DIAGNOSTIC BIOPSIES. DIAGNOSTIC ENB PROCEDURES WERE ASSOCIATED WITH A MINOR YET SIGNIFICANT DIFFERENCE IN TUMOR SIZE COMPARED TO NON-DIAGNOSTIC/INCONCLUSIVE ENB PROCEDURES (28 MM VS. 24 MM; P = 0.03). DIAG

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 18306711 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO OLYMPUS DEVICE CAUSE OR CONTRIBUTE TO ANY OF THE PATIENT COMPLICATIONS DESCRIBED IN THIS LITERATURE. NO OLYMPUS DEVICE MALFUNCTION DURING ANY PROCEDURE DESCRIBED IN THIS LITERATURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 18301262 ↗
• MalfunctionOct 2, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING AN UNSPECIFIED SURGERY, THE CUP OF THE DISPOSABLE BIOPSY FORCEPS DID NOT OPEN AT ALL. THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO ANOTHER DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THE USER FACILITY RETURNED THE DEVICE TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE TWO OPERATING WIRES HAD DETACHED FROM THE CUP'S OPERATING WIRE FIXING HOLES AND TWO CONTROL WIRES WERE BROKEN AND HAD MISSING PARTS. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE EVENT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17853644 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [AUTO-TRANSLATED] OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "DIAGNOSTIC YIELD AND SAFETY OF CP-EBUS-TBNA AND RP-EBUS-TBLB UNDER MODERATE SEDATION: A SINGLE-CENTER RETROSPECTIVE AUDIT". LITERATURE SUMMARY: THIS RETROSPECTIVE REVIEW STUDY AIMED TO DESCRIBE THE DIAGNOSTIC YIELD AND SAFETY OF CP-EBUS-TBNAS AND RP-EBUS-TBLBS WHEN PERFORMED UNDER MODERATE SEDATION IN 421 PATIENTS. THE DIAGNOSTIC YIELD OF THE CP-EBUS-TBNAS AND RP-EBUS-TBLBS WERE 62.5% AND 71.6%, RESPECTIVELY. THE MOST FREQUENT DIAGNOSIS FOR CP-EBUS-TBNAS WERE MALIGNANCY, SARCOIDOSIS, AND MYCOBACTERIUM INFECTION (50.9%, 6.3%, AND 4.2%, RESPECTIVELY). THE MOST FREQUENT DIAGNOSES FOR RP-EBUS - TBLBS WERE MALIGNANCY, ORGANIZING PNEUMONIA, AND MYCOBACTERIUM INFECTION (45.8%, 10% AND 3.7%, RESPECTIVELY) THIS STUDY CONCLUDES THAT PERFORMING CP-EBUS-TBNAS AND RP-EBUS-TBLBS UNDER MODERATE SEDATION IS SAFE AND PROVIDES GOOD DIAGNOSTIC YIELD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS BLEEDING - 50 PATIENTS. PNEUMOTHORAX - 1 PATIENT. HYPOXIA - 2 PATIENTS. RESPIRATORY COMPLAINTS OR FEVER - 10 PATIENTS. SINCE THE LITERATURE DESCRIBED "BF-UC260F WAS CONNECTED TO EU-ME1, WE SELECTED "BF-UC260FW" AS A REPRESENTATIV

  Patient problems: Fever; Genital Bleeding; Hypoxia; Pneumothorax; Unspecified Respiratory Problem

  MAUDE report 16159368 ↗
• MalfunctionOct 5, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS AN ISSUE WHILE USING THE DISPOSABLE BIOPSY FORCEPS. WHEN THE CUP WAS INSERTED THROUGH THE FORCEPS OPENING, THE CUP WAS CLOSED AND THE MUCOUS MEMBRANE WAS GRASPED, AND THE GREEN COVERING SHEATH IN FRONT OF THE OPERATION PART WAS PEELED OFF, EXPOSING THE INTERNAL COIL. WHEN IT WAS PULLED OUT FOR THE FIRST TIME, IT WAS PULLED OUT BY HOLDING THE GREEN SHEATH PART. WHEN THE CUSTOMER PULLED IT OUT FROM THE RESPIRATORY SCOPE, IT WAS PULLED OUT BY THE OPERATION PART; THERE WAS A SENSE OF RESISTANCE, AND THE SHEATH CAME OFF THE OPERATION PART. THE (DIAGNOSTIC) BIOPSY PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND A BIOPSY FORCEPS MALFUNCTION WAS FOUND; THE CONNECTION BETWEEN THE CUP AND THE WIRE HAD COME OFF. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544080 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: DIAGNOSTIC YIELD OF TRANSBRONCHIAL CRYOBIOPSY GUIDED BY RADIAL ENDOBRONCHIAL ULTRASOUND AND FLUOROSCOPY IN THE RADIOLOGICALLY SUSPECTED LUNG CANCER: A SINGLE INSTITUTION PROSPECTIVE STUDY BY VYTAUTAS ANKUDAVICIUS, ET AL. ABSTRACT TRANSBRONCHIAL CRYOBIOPSY (TBCB) IS BEING STUDIED IN THE DIAGNOSIS OF PERIPHERAL LUNG LESIONS; HOWEVER, THERE ARE ONLY A FEW CLINICAL STUDIES AROUND THE WORLD. THE AIM OF OUR STUDY WAS TO EVALUATE THE DIAGNOSTIC VALUES AND SAFETY OF TRANSBRONCHIAL CRYOBIOPSY FOR RADIOLOGICALLY SUSPECTED PERIPHERAL LUNG CANCER. THE PROSPECTIVE CLINICAL STUDY WAS EXECUTED FROM (B)(6) 2019 TO (B)(6) 2021 AT A TERTIARY CLINICAL CENTRE IN LITHUANIA. A TOTAL OF 48 PATIENTS OUT OF 102 UNDERWENT COMBINED PROCEDURES OF TRANSBRONCHIAL FORCEPS BIOPSY (TBFB) AND TBCB. DIAGNOSTIC VALUES AND SAFETY OUTCOMES OF TBFB AND TBCB WERE ANALYSED. THE SENSITIVITY, SPECIFICITY, POSITIVE PREDICTIVE VALUE (PPV), NEGATIVE PREDICTIVE VALUE (NPV) AND ACCURACY WERE 72.9%, 100%, 100%, 7.7%, AND 88.0% FOR TBFB, 85.1%, 100%, 100%, 12.5%, AND 93% FOR TBCB, AS WELL AS 91.5%, 100%, 100%, 20.0% AND 96.7% FOR THE COMBINED PROCEDURES, RESPECTIVELY, WITH A SIGNI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14167305 ↗
• MalfunctionFeb 8, 2022Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE CUP WAS OPENED. AND THE SUBJECT DEVICE WAS POINTED OUT THAT THE JOINT (HINGE PART) OF THE CUP WAS BROKEN AND ONE OF THE CUPS OPENED TOO MUCH. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. OMSC CONFIRMED THE FOLLOWING EVENT ON (B)(6) 2022 AND DETERMINED THAT IT WAS AN MEDICAL DEVICE REPORT (MDR) REPORTABLE EVENT. THE TWO CONTROL WIRES WERE BROKEN AND THERE WERE MISSING PARTS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13486922 ↗
• MalfunctionJul 12, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE EMAIL ON (B)(6) 2021 OF THE FOLLOWING INCIDENT THAT OCCURRED WITH THE SUBJECT DEVICE : DURING DIAGNOSTIC PROCEDURE, THE USER FACILITY ENCOUNTERED A PROBLEM WHEN USING THE THE SUBJECT DEVICE. THE BRONCHIAL SAMPLING FORCEPS BROKE DURING THE BIOPSY, INTO THE PATIENT. THE USER FACILITY DID AN EXPLORATION TO MAKE SURE THAT NO PIECE WAS LEFT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148447 ↗
• MalfunctionJan 15, 2020Break; Break

  DURING A BRONCHIAL BIOPSY, THE SUBJECT DEVICE WAS USED. THE FIRST AND THE SECOND BRONCHIAL BIOPSY WERE COMPLETED. IN THE THIRD BIOPSY, THE USER FELT STRANGE IN THE OPENING THE BIOPSY CUPS AND SHE REMOVED THE SUBJECT DEVICE FROM THE INSTRUMENT CHANNEL PORT. THEN, THE USER FOUND THAT THE WIRE PROTRUDED WITH THE BIOPSY CUPS CLOSED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. AFTER THE BIOPSY, THE USER CHECKED WHETHER OR NOT THE FRAGMENT OF THE WIRE REMAINED INSIDE THE PATIENT BY X-RAY EXAMINATION AND CONFIRMED NO FRAGMENT WAS INSIDE THE PATIENT. HOWEVER, THE USER WAS CONCERNED THAT THE FRAGMENT WOULD HAVE BEEN INSIDE THE PATIENT, BECAUSE A PART OF THE WIRE COULD NOT BE CONFIRMED BY X-RAY EXAMINATION. THERE WAS NO PATIENT INJURY REPORTED. ON JANUARY 10, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT BOTH MANIPULATION WIRES OF THE SUBJECT DEVICE CAME OFF FROM THE BIOPSY CUPS AND THE MANIPULATION WIRE WAS PARTLY MISSING. THIS IS THE REPORT REGARDING THE MISSING OF THE MANIPULATION WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9589857 ↗
• InjuryDec 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON DECEMBER 5, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿USE OF AN ULTRATHIN VS THIN BRONCHOSCOPE FOR PERIPHERAL PULMONARY LESIONS¿. THE LITERATURE REPORTED THE RESULT OF 356 CASES (ULTRATHIN BRONCHOSCOPE GROUP: 177CASES. THE RATIO OF MALE-TO-FEMALE RATIO WAS 107:70. THE MEDIAN AGE OF THE PATIENTS WAS 71 YEARS. THIN BRONCHOSCOPE GROUP: 179CASES. THE RATIO OF MALE-TO-FEMALE RATIO WAS 111:68. THE MEDIAN AGE OF THE PATIENTS WAS 72 YEARS.) OF THE MULTIPLE SAMPLING METHODS FOR THE DIAGNOSIS OF PERIPHERAL PULMONARY LESIONS FROM FEBRUARY 2013 TO AUGUST 2016. THE LITERATURE INDICATED THAT ULTRATHIN BRONCHOSCOPE (Y-0025 OR Y-0058), ULTRASONIC PROBE UM-S20-17S, AND/OR DISPOSABLE BIOPSY FORCEPS (FB-32D OR FB-233D IN SINGLE USE GUIDE SHEATH KIT K-201) MIGHT BE USED FOR ULTRATHIN BRONCHOSCOPE GROUP. THE LITERATURE ALSO INDICATED THAT THIN BRONCHOSCOPE (EVIS LUCERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE P260F; BF-P260F), SINGLE USE GUIDE SHEATH SG-200C IN SINGLE USE GUIDE SHEATH KIT K-201, DISPOSABLE BIOPSY FORCEPS FB-231D, GUIDING DEVICE CC-6DR-1, AND/OR SINGLE USE ASPIRATION NEEDLE NA-401D-1521 MIGHT BE USED FOR THIN BRONCHOSCOPE GROUP. IN THE SUBJECT CASES WITH

  Patient problems: Myocardial Infarction

  MAUDE report 9517484 ↗
• InjuryDec 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON DECEMBER 5, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿USE OF AN ULTRATHIN VS THIN BRONCHOSCOPE FOR PERIPHERAL PULMONARY LESIONS¿. THE LITERATURE REPORTED THE RESULT OF 356 CASES (ULTRATHIN BRONCHOSCOPE GROUP: 177CASES. THE RATIO OF MALE-TO-FEMALE RATIO WAS 107:70. THE MEDIAN AGE OF THE PATIENTS WAS 71 YEARS. THIN BRONCHOSCOPE GROUP: 179CASES. THE RATIO OF MALE-TO-FEMALE RATIO WAS 111:68. THE MEDIAN AGE OF THE PATIENTS WAS 72 YEARS.) OF THE MULTIPLE SAMPLING METHODS FOR THE DIAGNOSIS OF PERIPHERAL PULMONARY LESIONS FROM FEBRUARY 2013 TO AUGUST 2016. THE LITERATURE INDICATED THAT ULTRATHIN BRONCHOSCOPE (Y-0025 OR Y-0058), ULTRASONIC PROBE UM-S20-17S, AND/OR DISPOSABLE BIOPSY FORCEPS (FB-32D OR FB-233D IN SINGLE USE GUIDE SHEATH KIT K-201) MIGHT BE USED FOR ULTRATHIN BRONCHOSCOPE GROUP. THE LITERATURE ALSO INDICATED THAT THIN BRONCHOSCOPE (EVIS LUCERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE P260F ; BF-P260F), SINGLE USE GUIDE SHEATH SG-200C IN SINGLE USE GUIDE SHEATH KIT K-201, DISPOSABLE BIOPSY FORCEPS FB-231D, GUIDING DEVICE CC-6DR-1, AND/OR SINGLE USE ASPIRATION NEEDLE NA-401D-1521 MIGHT BE USED FOR THIN BRONCHOSCOPE GROUP. IN THE SUBJECT CASES WITH

  Patient problems: Pneumonia

  MAUDE report 9517482 ↗