BIOPSY FORCEPSRecalls & reported problems across all models

We found 18 models of BIOPSY FORCEPS by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between May 6, 2019 and Jul 24, 2024 — classified as 25 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Contamination” (13 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 BIOPSY FORCEPS problems

BIOPSY FORCEPS models

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

• BIOPSY FORCEPS FB-21K-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  11 reports
• BIOPSY FORCEPS FB-19K-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  10 reports
• BIOPSY FORCEPS FB-39Q-1

  FORCEPS, BIOPSY, NON-ELECTRIC
  8 reports
• BIOPSY FORCEPS FB-19C-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  6 reports
• BIOPSY FORCEPS FB-56D-1

  Laparoscope, general & plastic surgery
  6 reports
• BIOPSY FORCEPS FB-45Q-1

  FORCEPS, BIOPSY, NON-ELECTRIC
  4 reports
• BIOPSY FORCEPS FB-25K-1

  Forceps, Biopsy, Non-Electric
  3 reports
• BIOPSY FORCEPS FB-41ST-1

  Forceps, Biopsy, Non-Electric
  3 reports
• BIOPSY FORCEPS FB-28U-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  2 reports
• BIOPSY FORCEPS FB-15C-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  1 report
• BIOPSY FORCEPS FB-19SX-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  1 report
• BIOPSY FORCEPS FB-24K-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  1 report
• BIOPSY FORCEPS FB-24U-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  1 report
• BIOPSY FORCEPS FB-26N-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  1 report
• BIOPSY FORCEPS FB-36K-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  1 report
• BIOPSY FORCEPS FB-52C-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  1 report
• BIOPSY FORCEPS FB-52K-1

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  1 report
• BIOPSY FORCEPS FB-46Q-1

  FORCEPS, BIOPSY, NON-ELECTRIC
  1 report

Recent BIOPSY FORCEPS adverse event reports

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

• MalfunctionJul 24, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BIOPSY FORCEPS EXHIBITED PROBLEMS CAUSED BY IMPROPER REPROCESSING (FOREIGN MATTER). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816380 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "IMPACT OF A NEW DEDICATED SHEATH DEVICE FOR TISSUE SAMPLING OF BILIARY STRICTURE ON PATHOLOGICAL DIAGNOSTIC YIELD: RETROSPECTIVE STUDY". BACKGROUND AND STUDY AIMS. ENDOSCOPIC TRANSPAPILLARY BILIARY FORCEPS BIOPSY (TBFB) IS A COMMON METHOD FOR OBTAINING SPECIMENS FROM BILIARY LESIONS. ITS DIAGNOSTIC YIELD IS UNSATISFACTORY; TO OVERCOME THIS DISADVANTAGE, A DEDICATED SHEATH HAS BEEN DEVELOPED. THIS STUDY AIMED TO EVALUATE THE OUTCOMES OF CONVENTIONAL TBFB AND TBFB WITH A NOVEL SHEATH DEVICE. PATIENTS AND METHODS: CONSECUTIVE PATIENTS WHO UNDERWENT TBFB BETWEEN (B)(6) 2020 AND (B)(6) 2021 WERE RETROSPECTIVELY EVALUATED. THE RATE OF OBTAINING ADEQUATE SAMPLES, FAILED ATTEMPTS AT FORCEPS INSERTION INTO THE BILE DUCT, AND SENSITIVITY WERE COMPARED BETWEEN THE TWO GROUPS. RESULTS: NINETY-TWO PATIENTS WHO UNDERWENT 115 ENDOSCOPIC RETROGRADE: CHOLANGIOPANCREATOGRAPHIES (76 IN THE CONVENTIONAL GROUP VS. 39 IN THE DEDICATED SHEATH GROUP) WERE INCLUDED. THE RATES OF OBTAINING ADEQUATE SAMPLES, FAILED ATTEMPTS OF THE FORCEPS INTO THE BILE DUCT, AND SENSITIVITY WERE 72.4% VS. 89.7% (P = 0.03), 28.3% VS. 0% (P < 0.01), AND 66.7% VS. 88.9% (P =0.02

  Patient problems: Cholangitis; Pancreatitis

  MAUDE report 19562743 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERORAL CHOLANGIOSCOPY-GUIDED FORCEPS BIOPSY VERSUS FLUOROSCOPY-GUIDED FORCEPS BIOPSY FOR EXTRAHEPATIC BILIARY LESIONS". THE STUDY EVALUATED THE DIAGNOSTIC YIELD AND SAFETY OF FLUOROSCOPY-GUIDED FORCEPS BIOPSY (F-FB) FOR INDETERMINATE BILIARY LESIONS COMPARED WITH PERORAL CHOLANGIOSCOPY (POCS) AND POCS-GUIDED FORCEPS BIOPSY (POCS-FB) WHILE USING SIDEVIEWING DUODENOSCOPE (JF260V/TJF240V/TJF290V; OLYMPUS OPTICAL CO., LTD., TOKYO, JAPAN) WAS USED FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), 0.025-INCH HYDROPHILIC GUIDEWIRE (G-260-2545A; OLYMPUS OPTICAL CO., LTD. AND FB-45Q-1 (OLYMPUS OPTICAL CO., LTD.) BIOPSY FORCEPS. ACUTE PANCREATITIS - 9 PATIENTS. INFECTION (CHOLANGITIS) - 3 PATIENTS. PULMONARY DISORDER - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 5 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) :JF-260V, (B)(6): TJF-240, (B)(6) :TJF-Q290V, (B)(6) :FB-45Q-1, (B)(6): KD-V411M-0725. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER: (B)(6) : FB-45Q-1.

  Patient problems: Cholangitis; Pancreatitis

  MAUDE report 18314750 ↗
• MalfunctionDec 4, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE BIOPSY FORCEPS WERE NOT OPENING OR CLOSING. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE GRASPING CUPS PREVENTING IT FROM OPENING AND CLOSING. THERE WERE NO REPORTS OF PATIENT HARM. 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 18257761 ↗
• MalfunctionAug 9, 2023Device Reprocessing Problem; Contamination; Device Reprocessing Problem; Contamination

  THE CUSTOMER REPORTED TO OLYMPUS, THE BIOPSY FORCEPS CUP COULD NOT OPEN OR CLOSE. THE EVENT OCCURRED DURING PREPARATION FOR USE. THE INTENDED DIAGNOSTIC PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. DURING TESTING AND INSPECTION OF THE RETURNED DEVICE, IT WAS DISCOVERED THAT THERE WAS FOREIGN MATERIAL ON THE DEVICE DUE TO LACK OF PROPER REPROCESSING. THIS MEDWATCH REPORT IS BEING SUBMITTED TO CAPTURE THIS REPORTABLE MALFUNCTION WHICH WAS IDENTIFIED DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495080 ↗
• MalfunctionJul 27, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE BIOPSY FORCEPS HANDLE DID NOT MOVE AND THE CUP DID NOT OPEN WHEN TRYING TO SLIDE THE HANDLE. THE REPORTED ISSUE OCCURRED DURING PREPARATION OF USE FOR AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. UPON DEVICE RETURN AND EVALUATION, IT WAS OBSERVED THAT THERE WAS FOREIGN MATERIAL THAT ADHERED TO THE LINKAGE MECHANISM AND TO THE INSIDE OF THE CUP WHICH IS IDENTIFIED AS A REPORTABLE EVENT PER THE RISK SUMMARY APPLICATION (RSA). THE NEW AWARE DATE FOR THIS REPORTABLE MALFUNCTION IS (B)(6) 2023. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406948 ↗
• MalfunctionJun 29, 2023Contamination /Decontamination Problem; Failure to Clean Adequately; Contamination /Decontamination Problem; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BIOPSY FORCEPS EXHIBITED SLOW CUP MOVEMENT. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, FOREIGN MATERIAL WAS FOUND ADHERED TO THE LINKAGE MECHANISM DUE TO INSUFFICIENT CLEANING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT AFTER CLEANING/STERILIZING, THE ACTUAL PRODUCT WAS STORED FOR USE IN THE NEXT CASE AND BECAUSE THE PREVIOUS CASE DID NOT WORK WELL, THE CUSTOMER CHECKED THE OPERATION OF THE CUP, AND DISCOVERED THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226005 ↗
• MalfunctionApr 27, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED, THE BIOPSY FORCEPS HAD A PROBLEM WITH OPENING AND CLOSING THE CUP, WHEN BEING INSPECTED BEFORE USE IN AN UNSPECIFIED PROCEDURE. THE FORCEPS WAS NOTED TO HAVE BEEN USED 2-3 TIMES SINCE BEING RECEIVED BY THE CUSTOMER IN OCTOBER 2022. THE FORCEPS WAS REPROCESSUED USING AUTOCLAVE STERILIZATION SINCE THE SITE DID NOT HAVE ULTRASONIC CLEANING AVAILABLE. AFTER USE, THE FORCEPS WAS CLEANED, STERILZED AND STORED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823472 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FEASIBILITY OF MODIFIED ENDOBRONCHIAL ULTRASOUND-GUIDED INTRANODAL FORCEPS BIOPSY: A RETROSPECTIVE ANALYSIS." THE RETROSPECTIVE STUDY WAS TO ASSESS THE FEASIBILITY OF THE MODIFIED EBUS- INTRANODAL FORCEPS BIOPSY (IFB) TECHNIQUE, WHICH COMBINES STANDARD-SIZED FORCEPS WITH STANDARD ENDOBRONCHIAL ULTRASOUND (EBUS) TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) EQUIPMENT. A TOTAL OF 195 PATIENTS WERE INCLUDED. IFB WAS TECHNICALLY SUCCESSFUL IN 177 OF 195 CASES (90.8%). THE DIAGNOSTIC ACCURACY WAS 99.5% (193 OF 194 CASES). ONE PATIENT WAS LOST TO FOLLOW-UP. UNIVARIABLE ANALYSES DID NOT IDENTIFY ANY FACTORS INVOLVED IN TECHNICAL IFB FAILURE. AMONG THE DIAGNOSED CASES, THREE (1.5%) WERE DIAGNOSED. THE MEDIAN (RANGE) HISTOLOGICAL SCORES OF TBNA AND IFB SPECIMENS WERE 1.50 (0¿2) AND 1.67 (0¿2), RESPECTIVELY, WHICH WERE SIGNIFICANTLY DIFFERENT (P = 0.032). IN CONCLUSION, MODIFIED EBUS-IFB, COMBINING STANDARD-SIZED FORCEPS AND THE USUAL EQUIPMENT FOR EBUS TBNA, IS FEASIBLE WITH FEW MAJOR COMPLICATIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ PNEUMONIA - 1 PATIENT PNEUMOTHORAX REQUIRING THORACIC DRAINAGE - 1 PATIENT MINOR BLEEDING - 25 PATIENTS THI

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

  MAUDE report 16765412 ↗
• MalfunctionMar 6, 2023Contamination; Contamination

  IT WAS REPORTED THE CONNECTION BETWEEN THE DEVICE CUP AND THE WIRE CAME OFF, AND THE CUP COULD NOT BE OPENED OR CLOSED. THE REPORTED ISSUE OCCURRED AT PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED ISSUE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . DEVICE EVALUATION , FOREIGN MATERIAL (BROWN FOREIGN MATERIAL ) AS DESCRIBED BY SERVICE REPAIR FOUND AROUND THE BROKEN ARMS OF THE DEVICE. THIS REPORT IS BEING SUBMITTED DUE TO THE FINDING OF FOREIGN MATERIAL AROUND THE BROKEN ARMS OF THE DEVICE IDENTIFIED DURING DEVICE RETURN EVALUATION .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483741 ↗
• MalfunctionMar 3, 2023Break; Contamination; Material Twisted/Bent; Break; Contamination; Material Twisted/Bent

  AS REPORTED , THE CUP OF FB-21K-1 WAS BROKEN (BENT) DURING THE PRE-USE INSPECTION. ACCORDING TO THE REPORT, THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE (DIAGNOSTIC) WAS COMPLETED USING A SIMILAR DEVICE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483148 ↗
• MalfunctionDec 21, 2022Device Reprocessing Problem; Device Reprocessing Problem

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT THE REUSABLE BIOPSY FORCEPS WAS REPROCESSED WITHOUT USING AN ULTRASONIC CLEANER AS REQUIRED. INSTEAD, THE FORCEPS WAS REPORTEDLY IMMERSED IN ENDOFRESH AND THEN IN GLUTARALDEHYDE. IT WAS CONFIRMED THAT THE USER FACILITY KNEW THAT THE DEVICE NEEDED TO BE CLEANED BY IMPLEMENTING ULTRASONIC CLEANING. THERE WAS NO PATIENT INVOLVEMENT AS THE ISSUE OCCURRED DURING REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030577 ↗
• MalfunctionDec 9, 2022Break; Break

  THE CUSTOMER REPORTED THAT, DURING A BIOPSY OF THE URETER (FLEXIBLE URETEROSCOPY), THE FORCEPS COULD NOT BE OPENED WHEN THE BIOPSY WAS RETRIEVED. THE HANDLE WORKED BUT THE CUP ON THE SUBJECT DEVICE REMAINED CLOSED. THIS CAUSED A FIVE MINUTE DELAY IN THE PROCEDURE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE ARMS OF THE CAPS (A PART OF THE LINKAGE MECHANISM AT THE DISTAL END) WAS BROKEN OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (BROKEN ARMS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955244 ↗
• 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 ↗
• MalfunctionDec 6, 2022Device Reprocessing Problem; Contamination /Decontamination Problem; Device Reprocessing Problem; Contamination /Decontamination Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT THE BIOPSY FORCEPS CUP DID NOT OPEN DURING TESTING. IT WAS REPORTED THAT THE EVENT OCCURRED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, FOREIGN MATERIALS WERE FOUND ON THE ARMS OF THE FORCEPS CUPS (THE LINKAGE MECHANISM AT THE DISTAL END) DUE TO INCORRECT REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE NORMAL REPROCESSING PROCESS INVOLVES MANUAL CLEANING AFTER USE, FOLLOWED BY BRUSHING AND CLEANING WITH A DROPPER, THEN AUTOCLAVE STERILIZED. BUT LUBRICANT USE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924716 ↗

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