BIOPSY FORCEPS FB-39Q-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170030659), received between Feb 10, 2022 and Jun 18, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE "EFFICACY OF ENDOSCOPIC SAMPLINGS DURING INITIAL BILIARY DRAINAGE FOR CASES OF PANCREATIC HEAD CANCER: UNITED DIAGNOSTIC YIELDS OF MULTIPLE PATHOLOGICAL SAMPLINGS" BY HIROYUKI MATSUBAYASHI ET AL. ABSTRACT: BACKGROUND/OBJECTIVES: THE DIAGNOSTIC ABILITY OF ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION (EUS-FNA) HAS BEEN FULLY STUDIED; HOWEVER, THE EFFICACY OF OTHER ENDOSCOPIC SAMPLINGS (OESS) IS LESS CLEAR. THE AIM OF THIS STUDY WAS TO EXAMINE THE DIAGNOSTIC EFFICACIES OF OESS FOR PANCREATIC HEAD CANCER (PHC). METHODS: THE DIAGNOSTIC EFFICACIES OF ENDOSCOPIC SAMPLINGS WERE RETROSPECTIVELY ANALYZED IN 448 PHC CASES AND 63 CASES OF MASS-FORMING PANCREATITIS (MFP) DURING INITIAL TRANSPAPILLARY BILIARY DRAINAGE. THE OESS INCLUDED DUODENAL BIOPSY (118 PHCS AND 50 MFPS), BILIARY BIOPSY (218 AND 51) WITH CYTOLOGY (368 AND 53), AND PANCREATIC DUCT BIOPSY (23 AND 13) WITH CYTOLOGY (56 AND 43). EUS-FNA WAS CONDUCTED IN A DIFFERENT SESSION (149 AND 62). FACTORS ASSOCIATED WITH OES SENSITIVITY WERE ANALYZED. THE SENSITIVITY OF BILIARY BIOPSY WAS COMPARED BETWEEN 1.95 MM AND 1.8 MM FORCEPS. RESULTS: CANCER CELLS WERE CONFIRMED IN 87.9% OF TH

  Patient problems: Pancreatitis

  MAUDE report 13919716 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "BILIARY HEMOSTASIS USING AN ENDOSCOPIC PLASTIC STENT PLACEMENT FOR UNCONTROLLED HEMOBILIA CAUSED BY TRANSPAPILLARY FORCEPS BIOPSY (WITH VIDEO)." ABSTRACT: A (B)(6)-YEAR-OLD WOMAN WAS REFERRED TO OUR HOSPITAL FOR THE EXAMINATION AND TREATMENT OF JAUNDICE. AN OLYMPUS TRANSPAPILLARY FORCEPS BIOPSY FOR A LONG DISTAL BILE DUCT STRICTURE WAS PERFORMED USING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. IMMEDIATELY AFTER THE BIOPSY, MASSIVE BLEEDING WAS OBSERVED FROM THE ORIFICE OF THE PAPILLA. ALTHOUGH HEMOBILIA WAS PULSATILE, AN ENDOSCOPIC BILIARY PLASTIC STENT PLACEMENT WAS VERY EFFECTIVE IN ACHIEVING HEMOSTASIS. HOWEVER, A NASAL BILIARY CATHETER WAS REQUIRED BECAUSE A BLOOD CLOT CLOGGED THE STENT ON THE FOLLOWING DAY. ALTHOUGH COVERED SELF-EXPANDABLE METAL STENT (CSEMS) PLACEMENT HAS BEEN REPORTED FOR ACHIEVING ENDOSCOPIC HEMOSTASIS FOR BLEEDING, WE CHOSE TO USE A PLASTIC STENT TO REDUCE THE RISK OF POST-PROCEDURE PANCREATITIS. THE PLACEMENT OF BOTH AN ENDOSCOPIC BILIARY PLASTIC STENT AND A NASOBILIARY DRAINAGE CATHETER CAN BE AN ALTERNATIVE HEMOSTATIC TOOL TO CSEMSS. THE AUTHORS REPORTED: IMMEDIATELY AFTER THE BIOPSY, MASSIVE BLEE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Septic Shock; Unspecified Hepatic or Biliary Problem

  MAUDE report 13892870 ↗
• MalfunctionMar 24, 2022Difficult to Open or Close; Difficult to Open or Close

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "FACTORS AFFECTING THE YIELD OF ENDOSCOPIC TRANSPAPILLARY BILE DUCT BIOPSY FOR THE DIAGNOSIS OF PANCREATIC HEAD CANCER" BY HIROKAZU KIMURA, ET AL. THE STUDY WAS AIMED TO IDENTIFY FACTORS ASSOCIATED WITH A POSITIVE OUTCOME USING TRANSPAPILLARY BILIARY BIOPSY (TBB) FOR PANCREATIC HEAD CANCER (PHC). TOTAL 130 CASES THAT UNDERWENT TBB FOR INVESTIGATION OF DISTAL BILIARY STRICTURE WERE INCLUDED [62 CASES OF PHC, 36 CASES OF DISTAL BILIARY CANCER (DBC), AND 32 CASES OF BENIGN BILIARY STRICTURE (BBS)], AND THE FACTORS AFFECTING THE DIAGNOSTIC EFFICIENCY OF TBB WERE DETERMINED USING UNIVARIATE AND MULTIVARIATE LOGISTIC ANALYSES. THE STUDY REPORTED THAT ENDOSCOPIC BILIARY FORCEPS BIOPSY SHOWED A CARCINOMA COMPONENT IN 31 (50%) OF 62 PHC CASES, 33 (91.7%) OF 36 DBC CASES, AND NONE OF THE BPM CASES. THE CANCER-POSITIVE RATE FOR DBC WAS SIGNIFICANTLY HIGHER THAN THAT FOR PHC (P < 0.01). NO COMPLICATIONS OTHER THAN THREE (ONE CASE (1.61%) OF 62 PHC AND TWO CASES (5.56%) OF 36 DBC) CASES OF POST-ERCP PANCREATITIS WERE REPORTED. THE STUDY CONCLUDED WITH THE SUGGESTION THAT PHC WITH A HIGH LEVEL OF SERUM BILIRUBIN (>10 MG/DL) AND A HIGH CIRCUMFERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13889538 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "BILIARY GUIDEWIRE FACILITATES BILE DUCT BIOPSY AND ENDOSCOPIC DRAINAGE" BY TOSHIHIKO HIGASHIZAWA, ET AL. THE STUDY INVESTIGATED THE INTRODUCTION OF A GUIDEWIRE THROUGH BILE DUCT STRICTURES AND ACROSS THE BILIARY STENOSIS TO FIND OUT IF THAT FACILITATES THE TRANSPAPILLARY BILE DUCT BIOPSY AND SUBSEQUENT BILIARY DRAINAGE. TRANSPAPILLARY BILE DUCT BIOPSY WAS ATTEMPTED IN 61 CONSECUTIVE CASES, WITH EXTRAHEPATIC OR INTRAHEPATIC BILE DUCT STRICTURES DETECTED BY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE STUDY EVALUATED THE SUCCESS RATE OF ENDOSCOPIC BILIARY DRAINAGE AFTER PERFORMING BILE DUCT BIOPSY AND COMPLICATIONS. IN CONCLUSION, THE STUDY SAID THAT THE PATIENTS WITH BILE DUCT STRICTURES AT ERCP, THE PLACEMENT OF A GUIDEWIRE FACILITATES THE INSERTION OF BIOPSY FORCEPS AND SUBSEQUENT ENDOSCOPIC BILIARY DRAINAGE, AND THE BIOPSIES WERE POSITIVE FOR CANCER ARE MORE LIKELY WITH BILE DUCT CANCER THAN PANCREATIC CANCER. ONE PATIENT SUFFERED FROM ACUTE PANCREATITIS THAT RESOLVED WITHIN 48 H AFTER TREATMENT WITH ANALGESIA AND INTRAVENOUS FLUIDS. THE AUTHORS REPORTED USING 3 DIFFERENT OLYMPUS DEVICES AND DID NOT SPECIFY THE OLY

  Patient problems: Pancreatitis

  MAUDE report 13550110 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "FACTORS AFFECTING THE YIELD OF ENDOSCOPIC TRANSPAPILLARY BILE DUCT BIOPSY FOR THE DIAGNOSIS OF PANCREATIC HEAD CANCER" BY HIROKAZU KIMURA, ET AL. THE STUDY WAS AIMED TO IDENTIFY FACTORS ASSOCIATED WITH A POSITIVE OUTCOME USING TRANSPAPILLARY BILIARY BIOPSY (TBB) FOR PANCREATIC HEAD CANCER (PHC). TOTAL 130 CASES THAT UNDERWENT TBB FOR INVESTIGATION OF DISTAL BILIARY STRICTURE WERE INCLUDED [62 CASES OF PHC, 36 CASES OF DISTAL BILIARY CANCER (DBC), AND 32 CASES OF BENIGN BILIARY STRICTURE (BBS)], AND THE FACTORS AFFECTING THE DIAGNOSTIC EFFICIENCY OF TBB WERE DETERMINED USING UNIVARIATE AND MULTIVARIATE LOGISTIC ANALYSES. THE STUDY REPORTED THAT ENDOSCOPIC BILIARY FORCEPS BIOPSY SHOWED A CARCINOMA COMPONENT IN 31 (50%) OF 62 PHC CASES, 33 (91.7%) OF 36 DBC CASES, AND NONE OF THE BPM CASES. THE CANCER-POSITIVE RATE FOR DBC WAS SIGNIFICANTLY HIGHER THAN THAT FOR PHC (P < 0.01). NO COMPLICATIONS OTHER THAN THREE (ONE CASE (1.61%) OF 62 PHC AND TWO CASES (5.56%) OF 36 DBC) CASES OF POST-ERCP PANCREATITIS WERE REPORTED. THE STUDY CONCLUDED WITH THE SUGGESTION THAT PHC WITH A HIGH LEVEL OF SERUM BILIRUBIN (>10 MG/DL) AND A HIGH CIRCUMFERE

  Patient problems: Pancreatitis

  MAUDE report 13545985 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "TISSUE ACQUISITION FOR DIAGNOSIS OF BILIARY STRICTURES USING PERORAL CHOLANGIOSCOPY OR ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION" BY YUN NAH LEE, JONG HO MOON, ET AL.   THIS PROSPECTIVE SINGLE-CENTER OBSERVATIONAL STUDY AIMED TO EVALUATE THE USEFULNESS OF A DIAGNOSTIC APPROACH USING PERORAL CHOLANGIOSCOPY FORCEPS BIOPSY (POC-FB) OR ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION BIOPSY (EUS-FNAB) ACCORDING TO THE STRICTURE LOCATION IN PATIENTS WITH SUSPECTED MBS. AMONG A TOTAL OF 181 PATIENTS, INITIAL TPB SHOWED MALIGNANCY IN 122 PATIENTS, AND THE DIAGNOSTIC ACCURACY OF INITIAL TPB WAS 71.8% (95% CONFIDENCE INTERVAL [CI] 65.3%¿78.4 %]. OF THE 59 PATIENTS IN WHOM TPB WAS NEGATIVE FOR MALIGNANCY, 32 HAD PROXIMAL BILIARY STRICTURES AND UNDERWENT SUCCESSFUL POC. THE REMAINING 27 PATIENTS HAD DISTAL STRICTURES AND UNDERWENT SUCCESSFUL EUS-FNAB. THE ACCURACY OF MALIGNANCY DETECTION USING POC-FB FOR PROXIMAL BILIARY STRICTURES AND EUS-FNAB FOR DISTAL BILIARY STRICTURES WAS 93.6% (95%CI 84.9%-100%) AND 96.3% (95%CI 89.2%-100 %), RESPECTIVELY. THE OVERALL DIAGNOSTIC ACCURACY FOR THE COMBINATION OF TPB WITH EITHER POC-FB FOR P

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 13536568 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED THE FOLLOWING LITERATURE ARTICLE: DIRECT PERORAL CHOLANGIOSCOPY FOR DIAGNOSIS OF BILE DUCT LESIONS USING AN I-SCAN ULTRASLIM ENDOSCOPE: A PILOT STUDY BY Y. LEE, ET AL. THIS PROSPECTIVE STUDY WAS AIMED TO EVALUATE THE USEFULNESS OF PERORAL CHOLANGIOSCOPY (POC) USING A COMPUTED VIRTUAL CHROMOENDOSCOPY (CVC) IMAGE WITH I-SCAN COMPARED WITH THAT OF A CONVENTIONAL WHITE-LIGHT IMAGE (WLI) FOR THE DIAGNOSIS OF BILE DUCT LESIONS. TWENTY PATIENTS UNDERWENT I-SCAN EXAMINATION AND BIOPSY TO EVALUATE BILE DUCT MUCOSAL LESIONS. THE STUDY REPORTED A 100% TECHNICAL SUCCESS RATE OF POC USING I-SCAN. AND, DIRECT POC-GUIDED BIOPSY WAS TECHNICALLY SUCCESSFUL UNDER I-SCAN MODE IN 19 PATIENTS (95.0%). THE OVERALL DIAGNOSTIC ACCURACY OF THE TARGET BIOPSY REPORTED WAS 84.2%. MILD CHOLANGITIS WAS REPORTED IN ONE PATIENT (5.0%). IN CONCLUSION, THE STUDY SAID THAT DIRECT POC USING CVC BY I-SCAN MODE WAS HELPFUL WHEN EVALUATING BILE DUCT MUCOSAL LESIONS WITHOUT INTERFERENCE FROM THE BILE. FURTHER STUDIES MIGHT BE REQUIRED TO CONFIRM THE BENEFITS OF DIRECT POC WITH I-SCAN FOR PATIENTS WITH BILE DUCT LESIONS. COMPLICATIONS SUCH AS MILD CHOLANGITIS IN ONE PATIENT (5.0%) WAS OBSERVED. THE STUDY

  Patient problems: Inflammation; Unspecified Hepatic or Biliary Problem

  MAUDE report 13509333 ↗