ROTATABLE GRASPING FORCEPS FG-44NR-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170032196), received between Sep 9, 2020 and Apr 8, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Break; Break

  THE CUSTOMER REPORTED THE DISTAL END OF THE ROTATABLE GRASPING FORCEPS WAS FAULTY. THE ISSUE WAS FOUND WHEN PREPARING FOR A THERAPEUTIC PROCEDURE TO REMOVE A FOREIGN BODY. THIS WAS THE SECOND TIME THE DEVICE WAS GOING TO BE USED. THE DISTAL END BROKE OUTSIDE OF THE PATIENT'S BODY AND A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS NOT DELAYED OVER 15 MINUTES. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060136 ↗
• MalfunctionMar 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED, THE GRASPING FORCEPS HAD A BROWN CHARRED SUBSTANCE OBSERVED INSIDE THE STERILIZED PACK. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866151 ↗
• MalfunctionMar 1, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE ROTATABLE GRASPING FORCEPS HAD FOREIGN MATERIAL IN THE STERILE PACK. THIS ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18821965 ↗
• MalfunctionSep 14, 2022Corroded; Corroded

  THE CUSTOMER REPORTED THAT, DURING REPROCESSING OF THE SUBJECT DEVICE, A BROWN RUST-LIKE SUBSTANCE WAS FOUND FLOATING IN THE CLEANING LIQUID AFTER THE DEVICE WAS IMMERSED. THE USER DETERMINED THE SUBSTANCE DERIVED FROM THE SUBJECT DEVICE. THE PERSON IN CHARGE OF THE FACILITY POINTED OUT THAT THE SUBJECT DEVICE RUSTED QUICKLY AND DETERIORATED FASTER THAN OTHER REUSABLE TREATMENT TOOLS. THE SUBJECT DEVICE WAS NOT USED AND THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15424221 ↗
• InjuryOct 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ENDOSCOPIC TREATMENT OF INTRADUCTAL PANCREATIC STENT FRAGMENTATION". THE LITERATURE REPORTED THE RESULT OF 33 PATIENTS WITH ENDOSCOPIC TREATMENT OF INTRADUCTAL PANCREATIC STENT FRAGMENTATION USING UNSPECIFIED ENDOSCOPE AND OLYMPUS ROTATABLE GRASPING FORCEPS (FG-44NR-1 OR FG-V422PR) OR ELECTROSURGICAL SNARE (SD-9U-1) FROM 2001 TO 2015. IN THE SUBJECT CASES, PERIAMPULLARY DUODENAL BLEEDING OCCURRED IN 2 PATIENTS. THEREFORE, OMSC WILL SUBMIT 2 MEDICAL DEVICE REPORTS (MDR) DEPENDING ON THE DEVICE AND EVENT TYPE. THIS REPORT IS 1 OF 2 REPORTS OF ROTATABLE GRASPING FORCEPS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10624704 ↗
• MalfunctionSep 9, 2020Break; Break

  IT WAS REPORTED THAT FAULT WAS FOUND AT DISTAL END OF THE SUBJECT DEVICE AND THE PART BROKE OUTSIDE THE PATIENT DURING AN INSPECTION BEFORE USE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE ARM OF THE GRASPING JAWS WAS PARTIALLY MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10512474 ↗