DISPOSABLE GRASPING FORCEPS FG-52D (REF N5402730)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170375057), received between Feb 23, 2022 and Sep 13, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2022Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE CATHETER WAS BROKEN AT THE TOP OF THE HANDLE AND THE BASKET COULD NOT BE RETRACTED OR EXTENDED. TWO ADDITIONAL DEVICES WERE OPENED AND TESTED WITH THE SAME RESULT. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR THE SECOND DEVICE. THE FIRST DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE THIRD DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411422 ↗
• MalfunctionMay 24, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE BLUE-ON-BLACK HANDLE COATING ON THE SUBJECT DEVICE SPRUNG OPEN AND THE DEVICE COULD NO LONGER BE USED. A SECOND DEVICE OF THE SAME MODEL WAS OPENED, AND THE SAME ISSUE OCCURRED. A THIRD DEVICE OF THE SAME MODEL WAS THEN USED TO COMPLETE THE INTENDED PROCEDURE WITHOUT ISSUE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE SECOND DEVICE, UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH THE FIRST DEVICE IS BEING SUBMITTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488050 ↗
• MalfunctionMay 24, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE BLUE-ON-BLACK HANDLE COATING ON THE SUBJECT DEVICE SPRUNG OPEN AND THE DEVICE COULD NO LONGER BE USED. A SECOND DEVICE OF THE SAME MODEL WAS OPENED, AND THE SAME ISSUE OCCURRED. A THIRD DEVICE OF THE SAME MODEL WAS THEN USED TO COMPLETE THE INTENDED PROCEDURE WITHOUT ISSUE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE FIRST DEVICE, UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH THE SECOND DEVICE IS BEING SUBMITTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488025 ↗
• InjuryFeb 23, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC PERCUTANEOUS CHOLEDOCHOLITHIASIS TREATMENT ON AN UNKNOWN NUMBER OF PATIENTS, THE OLYMPUS DEVICE HAD DIFFICULTY COLLECTING THE BILE DUCT STONES. THE CUSTOMER REPORTED THERE WAS AN UNKNOWN NUMBER OF PROCEDURES EXTENDED FOR FIVE (5) HOURS DUE TO THIS DIFFICULTY COLLECTING THE BILE DUCT STONES. THE PROCEDURES WERE COMPLETED AND NO HEALTH HAZARDS OCCURRED. ATTEMPTS TO GATHER MORE INFORMATION ARE IN PROGRESS.

  Patient problems: Insufficient Information

  MAUDE report 13588711 ↗