DISPOSABLE GRASPING FORCEPS FG-51DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170375040), received between Jun 6, 2022 and Jan 15, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2025

  ATTEMPTED TO PULL THE BASKET BACK INTO THE SHEATH TO INSERT DEVICE DOWN BRONCHOSCOPY SCOPE, BUT BASKET WOULD NOT MOVE DESPITE CONTROL HANDLE OPENING AND CLOSING. UNABLE TO USE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157836 ↗
• MalfunctionDec 9, 2022Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THE BASKET ON THE SUBJECT DEVICE DID NOT OPEN DURING USE IN A BRONCHOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE BASKET COULD NOT BE CLOSED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (UNABLE TO CLOSE BASKET). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950507 ↗
• 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 THIRD DEVICE. THE FIRST DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE SECOND DEVICE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411418 ↗
• MalfunctionSep 9, 2022Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE USER, PRIOR TO AN UNKNOWN PROCEDURE, THREE DISPOSABLE GRASPING FORCEPS COULD NOT BE OPENED AND/OR CLOSED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. IT WAS FURTHER REPORTED, THIS TYPE OF PROCEDURE TAKES 14 MINUTES, HOWEVER; THE START OF THIS PROCEDURE WAS DELAYED BY 30 MINUTES DUE TO THIS EVENT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. THE FIRST GRASPING FORCEPS IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE SECOND GRASPING FORCEPS IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392064 ↗
• MalfunctionSep 9, 2022Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE USER, PRIOR TO AN UNKNOWN PROCEDURE, THREE DISPOSABLE GRASPING FORCEPS COULD NOT BE OPENED AND/OR CLOSED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. IT WAS FURTHER REPORTED, THIS TYPE OF PROCEDURE TAKES 14 MINUTES, HOWEVER; THE START OF THIS PROCEDURE WAS DELAYED BY 30 MINUTES DUE TO THIS EVENT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. THE FIRST GRASPING FORCEPS IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE THIRD GRASPING FORCEPS IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392025 ↗
• MalfunctionJul 1, 2022Difficult to Open or Close; Difficult to Open or Close

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE USER, PRIOR TO AN UNKNOWN PROCEDURE, THREE DISPOSABLE GRASPING FORCEPS COULD NOT BE OPENED AND/OR CLOSED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. IT WAS FURTHER REPORTED, THIS TYPE OF PROCEDURE TAKES 14 MINUTES, HOWEVER; THE START OF THIS PROCEDURE WAS DELAYED BY 30 MINUTES DUE TO THIS EVENT. THERE WERE NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14894051 ↗
• MalfunctionJun 6, 2022Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT WHEN THE DISPOSABLE GRASPING FORCEPS BASKET WAS OPENED AND CLOSED, THE GRIP PART FAILED TO CLOSE AFTER OPENING AND COULD NOT BE STORED IN THE SHEATH. TWO SIMILAR DEVICES WERE USED; HOWEVER, THE ISSUE PERSISTED. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THE PROCEDURE WAS COMPLETED WITH A FOURTH DEVICE SUCCESSFULLY. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE SECOND OCCURRENCE. THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE FIRST OCCURRENCE. THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE THIRD OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601748 ↗
• MalfunctionJun 6, 2022Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT WHEN THE DISPOSABLE GRASPING FORCEPS BASKET WAS OPENED AND CLOSED, THE GRIP PART FAILED TO CLOSE AFTER OPENING AND COULD NOT BE STORED IN THE SHEATH. TWO SIMILAR DEVICES WERE ATTEMPTED; HOWEVER, THE ISSUE PERSISTED. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FOURTH DEVICE . THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE FIRST OCCURRENCE. THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE SECOND OCCURRENCE. THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE THIRD OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601644 ↗