DISPOSABLE GRASPING FORCEPS FG-401QRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170160929), received between Mar 10, 2023 and Oct 8, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE STONE BECAME IMPACTED WHILE BEING HELD BY THE BASKET OF THE DISPOSABLE GRASPING FORCEPS DURING LITHOTRIPSY. THE STONE WAS CRUSHED BY ADDING A BAMBECK. THE PROCEDURE WAS COMPLETED BY SCRAPING THE STONE OUT WITH THE BASKET. THERE WERE NO PROBLEMS WITH THE PATIENT'S HEALTH. NO ADDITIONAL TREATMENT AND NO ADDITIONAL ANESTHESIA WERE REQUIRED. THE PROCEDURE WAS EXTENDED BY ABOUT 20 TO 30 MINUTES. THOUGH THE PROCEDURE WAS PROLONGED, THE DELAY WAS MINIMAL. THERE IS NO INDICATION THAT EMERGENCY MEASURES WERE DONE TO REMOVE THE BASKET. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396070 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED, "A CASE OF HEPATIC PORTAL VENOUS GAS DUE TO ERCP". LITERATURE SUMMARY: A 93-YEAR-OLD MAN WAS DIAGNOSED WITH ACUTE OBSTRUCTIVE CHOLANGITIS DUE TO CHOLEDOCHOLITHIASIS. ENDOSCOPIC PAPILLARY BALLOON DILATATION WAS PERFORMED AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). AT THE TIME OF ENDOSCOPIC BILE DUCT STONE REMOVAL, THE BASKET CATHETER MIGHT HAVE INJURED THE CYSTIC DUCT. THE PATIENT EXPERIENCED EPIGASTRIC PAIN 4 HOURS AFTER ERCP. THE FOLLOWING MORNING, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED AIR IN THE CYSTIC DUCT AND THE PORTAL BRANCHES OF THE RIGHT HEPATIC LOBE. THE PATIENT WAS DIAGNOSED WITH HEPATIC PORTAL VENOUS GAS (HPVG) AND CHOLECYSTITIS DUE TO OBSTRUCTION OF THE BILE DUCT CAUSED BY SUSPECTED DAMAGE TO THE BILE DUCT. AN ENHANCED CT 1 HOUR LATER SHOWED NO SIGNS OF INTESTINAL NECROSIS, AND THE PORTAL VENOUS GAS DECREASED. CONSEQUENTLY, CONSERVATIVE TREATMENT WAS PERFORMED FOR HPVG AND PERCUTANEOUS TRANSHEPATIC GALLBLADDER DRAINAGE WAS PERFORMED FOR CHOLECYSTITIS. PATHOLOGICAL EXAMINATION REVEALED EVIDENCE OF CHRONIC CHOLECYSTITIS AND AN AREA OF MUCOSAL DEFECT IN A PART OF THE BILE DUCT. THE INFLAMM

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16524603 ↗