DISPOSABLE GRASPING FORCEPS FG-55DRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04953170375071), received between Mar 7, 2022 and Sep 30, 2022 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE CUSTOMER REPORTED THE TUBES OF THE BASKET WERE BROKEN AND ACCUMULATED. THE CUSTOMER INTENDED TO USE THE DEVICE TO REMOVE FOREIGN BODIES FROM PATIENT'S BRONCHIAL TUBES. THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER 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 15513414 ↗
• MalfunctionSep 30, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE CUSTOMER REPORTED THE TUBES OF THE BASKET WERE BROKEN AND ACCUMULATED. THE CUSTOMER INTENDED TO USE THE DEVICE TO REMOVE FOREIGN BODIES FROM PATIENT'S BRONCHIAL TUBES. THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER 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 15513235 ↗
• MalfunctionSep 30, 2022Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  THE CUSTOMER REPORTED THE TUBES OF THE BASKET WERE BROKEN AND ACCUMULATED. THE CUSTOMER INTENDED TO USE THE DEVICE TO REMOVE FOREIGN BODIES FROM PATIENT'S BRONCHIAL TUBES. THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER 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 EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15512323 ↗
• 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 FIRST DEVICE. THE SECOND 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 15411398 ↗
• MalfunctionSep 9, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE BASKET DID NOT EXTEND AND THE TUBE CAME LOOSE MAKING THE DEVICE UNUSABLE. ADDITIONAL DETAILS WERE REQUESTED REGARDING THE REPORTED EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION, THE TUBE WAS FOUND TO BE BROKEN WHICH PREVENTED THE BASKET FROM OPENING. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391245 ↗
• MalfunctionJun 14, 2022Mechanical Problem; Mechanical Problem

  UPON ATTEMPTING TO USE THE DEVICE, THE BASKET DID NOT OPEN. ADDITIONAL ATTEMPTS TO OPEN THE BASKET WERE SUCCESSFUL AND THE DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE, A BILE DUCT LITHOTRIPSY. THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS. THIS IS REPORT #2 OF 2 DUE TO MULTIPLE DEVICES REPORTED - REFERENCE REPORT PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL DEVICE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14686638 ↗
• MalfunctionJun 14, 2022Mechanical Problem; Mechanical Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT THE BASKET DID NOT OPEN AND THE DEVICE COULD NOT BE USED. THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING PREPARATION FOR USE FOR A BILE DUCT LITHOTRIPSY. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS. ANOTHER DEVICE OF IDENTICAL MODEL WAS OPENED AND THE BASKET WOULD NOT OPEN INITIALLY; SUBSEQUENT ATTEMPTS TO OPEN THE BASKET WERE SUCCESSFUL AND THE DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE. THIS IS REPORT #1 OF 2 DUE TO MULTIPLE DEVICES REPORTED - REFERENCE REPORT PATIENT IDENTIFIER #(B)(6) FOR ADDITIONAL DEVICE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685734 ↗
• 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 THIRD OCCURRENCE. THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE FIRST OCCURRENCE. THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) IS THE SECOND OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601709 ↗
• MalfunctionMay 24, 2022Difficult to Open or Close; Material Split, Cut or Torn; Difficult to Open or Close; Material Split, Cut or Torn

  THE PHYSICIAN AT THE USER FACILITY REPORTED THAT DURING A LAPAROTOMY PROCEDURE, THE SUBJECT DEVICE WAS BEING USED TO REMOVE COMMON BILE DUCT STONES VIA A CHOLANGIOSCOPE (CHF-V2), AND EVENTS SUCH AS ¿THE WIRE AT THE ROOT BEING CUT OR THE BASKET BEING UNABLE TO OPEN AND CLOSE WHEN PULLED LIGHTLY IMMEDIATELY AFTER OPENING¿ OCCURRED. THE BILE DUCT STONES WERE REMOVED WITH AN ALTERNATE DEVICE (FG-52D). THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE USER FACILITY LATER REPORTED THAT THE SAME ISSUE OCCURRED TWICE DURING THE SAME PATIENT PROCEDURE WITH TWO DIFFERENT DEVICES OF THE SAME MODEL. THIS REPORT IS BEING SUBMITTED FOR THE SECOND DEVICE, UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). THE REPORT FOR THE FIRST DEVICE IN THIS EVENT WAS SUBMITTED UNDER MEDWATCH 8010047-2022-08360, WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488308 ↗
• MalfunctionMay 17, 2022Difficult to Open or Close; Material Split, Cut or Torn; Difficult to Open or Close; Material Split, Cut or Torn

  OLYMPUS (OMSC) WAS INFORMED BY THE PHYSICIAN AT THE USER FACILITY THAT THE DISPOSABLE GRASPING FORCEPS WAS BEING USED TO REMOVE COMMON BILE DUCT STONES VIA A CHOLANGIOSCOPE (CHF-V) DURING A LAPAROTOMY PROCEDURE, ¿REPORTS OF EVENTS SUCH AS THE WIRE AT THE ROOT BEING CUT OR THE BASKET BEING UNABLE TO OPEN AND CLOSE WHEN PULLED LIGHTLY IMMEDIATELY AFTER OPENING IS RECEIVING. ¿THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE (FG-52D). NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14423727 ↗
• MalfunctionMay 12, 2022Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT, DURING PREPARATION FOR A PROCEDURE TO REMOVE A FOREIGN BODY FROM THE PATIENT, THE BASKET COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THE PATIENT WAS NOT UNDER ANESTHESIA WHEN THE EVENT OCCURRED AND THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14371271 ↗
• MalfunctionApr 11, 2022Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED TO OLYMPUS DURING PREPARATION FOR USE PRIOR TO A BRONCHOSCOPY, THE EXTRACTION BASKET WAS INSPECTED AND FOUND TO NOT CLOSE WITH THE WHOLE TUBE PILED UP IN THE HANDLE. THE MALFUNCTIONED DEVICE WAS NOT USED FOR THE PROCEDURE. THE FACILITY USED AN UNSPECIFIED TOOL TO REMOVE THE FOREIGN ITEM FROM THE PATIENT. THERE WAS A PROCEDURAL DELAY OF FIFTEEN MINUTES INCLUDING A PROLONGATION OF ANESTHESIA. THE FACILITY REPORTED NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074820 ↗
• InjuryMar 7, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTS DURING A BRONCHOSCOPIC INTERVENTION PROCEDURE USING DISPOSABLE GRASPING FORCEPS, THE CABLE SWIRLED UP AND THE GRASPER DOES NOT CLOSE AT THE FRONT. THIS OCCURRED WITH A TOTAL OF FIVE GRASPERS FROM THE SAME BATCH (LOT). THIS CAUSED A DELAY IN THE PROCEDURE RESULTING IN A DECLINE IN THE PATIENT¿S CONDITION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT FORCEPS DEVICE AND NO FURTHER CONSEQUENCES TO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 1 OF 5. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 2 OF 5. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 3 OF 5. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 4 OF 5. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 5 OF 5.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13683800 ↗
• InjuryMar 7, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTS DURING A BRONCHOSCOPIC INTERVENTION PROCEDURE USING DISPOSABLE GRASPING FORCEPS, THE CABLE SWIRLED UP AND THE GRASPER DOES NOT CLOSE AT THE FRONT. THIS OCCURRED WITH A TOTAL OF FIVE GRASPERS FROM THE SAME BATCH (LOT). THIS CAUSED A DELAY IN THE PROCEDURE RESULTING IN A DECLINE IN THE PATIENT¿S CONDITION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT FORCEPS DEVICE AND NO FURTHER CONSEQUENCES TO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 1 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 2 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 3 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 4 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 5 OF 5.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13683788 ↗
• InjuryMar 7, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTS DURING A BRONCHOSCOPIC INTERVENTION PROCEDURE USING DISPOSABLE GRASPING FORCEPS, THE CABLE SWIRLED UP AND THE GRASPER DOES NOT CLOSE AT THE FRONT. THIS OCCURRED WITH A TOTAL OF FIVE GRASPERS FROM THE SAME BATCH (LOT). THIS CAUSED A DELAY IN THE PROCEDURE RESULTING IN A DECLINE IN THE PATIENT¿S CONDITION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT FORCEPS DEVICE AND NO FURTHER CONSEQUENCES TO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 1 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 2 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 3 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 4 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 5 OF 5.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13683759 ↗
• InjuryMar 7, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTS DURING A BRONCHOSCOPIC INTERVENTION PROCEDURE USING DISPOSABLE GRASPING FORCEPS, THE CABLE SWIRLED UP AND THE GRASPER DOES NOT CLOSE AT THE FRONT. THIS OCCURRED WITH A TOTAL OF FIVE GRASPERS FROM THE SAME BATCH (LOT). THIS CAUSED A DELAY IN THE PROCEDURE RESULTING IN A DECLINE IN THE PATIENT¿S CONDITION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT FORCEPS DEVICE AND NO FURTHER CONSEQUENCES TO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 1 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 2 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 3 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 4 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 5 OF 5.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13683749 ↗
• InjuryMar 7, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTS DURING A BRONCHOSCOPIC INTERVENTION PROCEDURE USING DISPOSABLE GRASPING FORCEPS, THE CABLE SWIRLED UP AND THE GRASPER DOES NOT CLOSE AT THE FRONT. THIS OCCURRED WITH A TOTAL OF FIVE GRASPERS FROM THE SAME BATCH (LOT). THIS CAUSED A DELAY IN THE PROCEDURE RESULTING IN A DECLINE IN THE PATIENT¿S CONDITION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT FORCEPS DEVICE AND NO FURTHER CONSEQUENCES TO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 1 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 2 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 3 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 4 OF 5; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE 5 OF 5.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13683744 ↗