BIOPSY FORCEPS FB-45Q-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170030710), received between Feb 10, 2022 and Dec 12, 2023 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFECT OF MAPPING BIOPSY ON SURGICAL MANAGEMENT OF CHOLANGIOCARCINOMA" BY KOJIRO TAURA ET AL. THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE ROLE OF ENDOSCOPIC TRANSPAPILLARY MAPPING BIOPSY (MB) IN DETERMINING THE SURGICAL INDICATION AND PROCEDURE, AND ITS EFFECT ON SURGICAL RADICALITY REGARDING THE BILE DUCT (BD) MARGIN FOR CHOLANGIOCARCINOMA (CCA) PATIENTS. A TOTAL OF 115 MB PROCEDURES WERE PERFORMED IN 80 PATIENTS WHO UNDERWENT TUMOR RESECTION. THE STUDY REPORTED THAT 60 (75.0%) PATIENTS TOLERATED MB WITHOUT ANY COMPLICATIONS EXCEPT PANCREATITIS OBSERVED IN 20 (25.0%) PATIENTS. THE INCIDENCE OF BILE LEAKAGE WAS SIGNIFICANTLY LOWER IN THE MB GROUP IN BOTH THE ANASTOMOTIC SITE (5.0% VS. 16.3%) AND THE PARENCHYMAL SURFACE. THE STUDY CONCLUDED MB WAS SAFE AND EFFICACIOUS IN SELECTING OPTIMAL SURGICAL PROCEDURES FOR CHOLANGIOCARCINOMA. THE AUTHORS USED MULTIPLE OLYMPUS DEVICES AND DID NOT SPECIFY THE DEVICES USED IN RELATION TO THE ADVERSE EVENTS EXPERIENCED. THEREFORE, ALL OLYMPUS DEVICES WILL BE REPORTED FOR THE FOLLOWING ADVERSE EVENTS: POSTOPERATIVELY, PATIENTS HAD MILD, MODERATE AND SEVERE PANCREATITIS, POST-HEPATECTOMY LIVER FAI

  Patient problems: Fistula; Liver Failure; Pancreatitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 13543614 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED THE FOLLOWING LITERATURE ARTICLE: ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE NEEDLE ASPIRATION FOR EXTRAHEPATIC CHOLANGIOCARCINOMA: A SAFE TISSUE SAMPLING MODALITY BY T. ONOYAMA, ET AL. THE STUDY EVALUATED THE EFFICACY AND SAFETY OF ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE NEEDLE ASPIRATION (EUS-FNA) FOR DIAGNOSING EXTRAHEPATIC CHOLANGIOCARCINOMA (ECC) COMPARED WITH ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TISSUE SAMPLING. PATIENTS WHO UNDERWENT EUS-FNA OR ERCP TISSUE SAMPLING TO DIFFERENTIATE ECC FROM BENIGN BILIARY DISEASE WERE ENROLLED RETROSPECTIVELY BETWEEN OCTOBER 2011 AND MARCH 2017. THE DIAGNOSTIC PERFORMANCES OF EUS-FNA AND ERCP TISSUE SAMPLING BASED ON PATHOLOGICAL EVALUATION. THE STUDY COMPARED ADVERSE EVENTS IN EUS-FNA AND ERCP TISSUE SAMPLING. SEVENTY-THREE (73) PATIENTS WITH BILIARY DISEASE WERE ENROLLED. EUS-FNA AND ERCP WERE PERFORMED IN 19 AND 54 PATIENTS, RESPECTIVELY. SENSITIVITY, SPECIFICITY, AND ACCURACY OF ERCP TISSUE SAMPLING WERE 76.0%, 100%, AND 88.9%, RESPECTIVELY, AND FOR EUS-FNA THESE WERE 81.8%, 87.5%, AND 84.2%, RESPECTIVELY. STATISTICAL VALUES OF ERCP TISSUE SAMPLING AND EUS-FNA WERE NOT SIGNIFICANTLY DIFFERENT. THE ADVERSE EVE

  Patient problems: Inflammation; Pancreatitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 13528545 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED THE FOLLOWING LITERATURE ARTICLE: DIAGNOSTIC PERFORMANCE OF A NEW ENDOSCOPIC SCRAPER FOR MALIGNANT BILIARY STRICTURES: A MULTICENTER PROSPECTIVE STUDY BY Y. SAKUMA, ET AL. THIS MULTICENTER SINGLE-ARM PROSPECTIVE STUDY WAS AIMED TO INVESTIGATE THE DIAGNOSTIC PERFORMANCE OF A NEWLY DEVELOPED ENDOSCOPIC DEVICE WITH ¿SCRAPING LOOPS¿ IN COMBINATION WITH CONVENTIONAL BIOPSY FORCEPS. ONE HUNDRED AND TWENTY-THREE (123) PATIENTS WITH SUSPECTED MALIGNANT BILIARY STRICTURES WERE INCLUDED. THE STUDY REPORTED THAT 83.7% (103/123), 93.5% (115/123), AND 95.9% (118/123) OF PATIENTS WERE USING BIOPSY FORCEPS, THE NEW DEVICE, AND THEIR COMBINATION, RESPECTIVELY. COMPLICATIONS SUCH AS POST-ERCP PANCREATITIS (PEP) OCCURRED. ALL THE CASES OF PEP OCCURRED IN PATIENTS WITHOUT ENDOSCOPIC SPHINCTEROTOMY (EST). EST WAS PERFORMED IN 49 (39.8%) PATIENTS. THE PEP WAS CONSIDERED MILD IN 10 (8.1%) PATIENTS, MODERATE IN 0 (0%), AND SEVERE IN 1 (0.8%). OTHER ADVERSE EVENTS OR SUBSEQUENT DEATHS WERE NOT OBSERVED. IN CONCLUSION, THE STUDY DEMONSTRATED THAT THE NEW ENDOSCOPIC SCRAPER SHOWED BETTER PERFORMANCE CONCERNING TUMOR ACCESSIBILITY, LARGER SAMPLE YIELD, AND HIGHER CANCER DETECTABILITY THAN CO

  Patient problems: Pancreatitis

  MAUDE report 13509354 ↗