GRASPING FORCEPS FG-53SX-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04953170049040), received between Sep 27, 2018 and Jan 14, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN MATTER ADHESION DURING PRE-USE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152725 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GRASPING FORCEPS JAWS COMPONENT BROKE OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516973 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE GRASPING FORCEPS PARTS BROKE OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831145 ↗
• MalfunctionJul 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GRASPING FORCEPS EXHIBITED BROWN FOREIGN MATERIAL ON THE LINK MECHANISM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810322 ↗
• MalfunctionJul 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GRASPING FORCEPS EXHIBITED BROWN FOREIGN MATERIAL ON THE LINK MECHANISM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807307 ↗
• MalfunctionJun 14, 2024Break; Break

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GRASPING FORCEPS EXHIBITED A BROKEN PART. NO REPORTS OF PARTS FALLEN INTO BODY. NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543494 ↗
• MalfunctionApr 24, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE GRASPING FORCEPS HAD BURNT DEPOSITS. THE ISSUE OCCURRED DURING RECEIPT INSPECTION FOR A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173636 ↗
• MalfunctionApr 15, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GRASPING FORCEPS EXHIBITED FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19107021 ↗
• MalfunctionApr 9, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT A BROWN FOREIGN SUBSTANCE WAS FOUND ATTACHED TO PART OF THE FORCEPS SLIDER OF THE GRASPING FORCEPS. THE ISSUE WAS FOUND WHEN AUTOCLAVE STERILIZATION WAS DONE AFTER A UROLOGY PROCEDURE. THE CUSTOMER SUSPECTED THE FOREIGN MATERIAL MAY HAVE BEEN LEFT UNWASHED DURING CLEANING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069966 ↗
• MalfunctionMar 28, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GRASPING FORCEPS EXHIBITED FOREIGN MATERIAL ADHERED TO THE LINK MECHANISM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999468 ↗
• MalfunctionDec 21, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE GRASPING FORCEPS THAT DURING PRE-USE INSPECTION, THE USER NOTICED THAT THE GRASPING FORCEPS TIP GRIP WAS DAMAGED AND DID NOT USE IT. THE USER COMPLETED THE PROCEDURE BY CHANGING TO ANOTHER TREATMENT TOOL. NO EFFECT ON PATIENTS. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, AND THE EVALUATION FOUND THAT GRASPING FORCEPS HAD BROWNISH FOREIGN MATTER ADHERING TO IT, AND BRITTLE FRACTURE DUE TO CORROSION WAS OBSERVED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378348 ↗
• MalfunctionSep 14, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE GRASPING FORCEPS SLIDER OF THE OPERATION PART MOVED ONCE, BUT AFTER THAT IT STOPPED MOVING AND THE GRIP PART DID NOT OPEN. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT PROPER REPROCESSING AFTER USE WAS NOT PERFORMED. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743894 ↗
• MalfunctionSep 2, 2023Component Missing; Component Missing

  THE CUSTOMER REPORTED TO OLYMPUS THE GRASPING FORCEPS DID NOT CLOSE AT FIRST TIME USE AFTER INITIAL PRODUCT DELIVERY. THE REPORTED ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674950 ↗
• MalfunctionAug 28, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE GRASPING FORCEPS DID NOT CLOSE WHEN USING THE PRODUCT. THE REPORTED ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. DURING THE EVALUATION OF THE RETURNED DEVICE, CORROSION WAS FOUND, AND THE FORCEPS TIME MECHANISM WAS DAMAGED WHICH IS IDENTIFIED AS A REPORTABLE EVENT PER THE RISK SUMMARY APPLICATION (RSA). THE NEW AWARE DATE FOR THIS REPORTABLE MALFUNCTION IS 25AUG2023. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17634507 ↗
• MalfunctionAug 24, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED THAT DURING THE PRE-USE INSPECTION, THE TIP OF THE GRASPING FORCEPS WAS BROKEN, MAKING IT IMPOSSIBLE TO GRIP. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION, FOREIGN MATERIAL WAS OBSERVED, AND FOUND TO BE CAUSED BY IMPROPER REPROCESSING AFTER USE. NO REPORTS OF PATIENT OR USER HARM WERE REPORTED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610894 ↗
• MalfunctionAug 4, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT HIS OLYMPUS GRASPING FORCEPS WAS EXPERIENCING A PROBLEM WITH THE TIP OF THE FORCEPS OPENING POORLY. THE CUSTOMER WENT ON TO CONFIRM THE DEVICE¿S REPROCESSING STEPS BEFORE NOTING THAT THIS ISSUE OCCURS EVERY 2-3 MONTHS AT THEIR FACILITY. THE CUSTOMER CONFIRMED THAT THIS EVENT DID NOT RESULT IN ANY PATIENT HARM. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE INSUFFICIENT REPROCESSING NOTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17460262 ↗
• MalfunctionJun 5, 2023Corroded; Device Dislodged or Dislocated; Corroded; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE GRASPING FORCEPS STOPPED OPENING. THE EVENT OCCURRED DURING A DIAGNOSTIC PROCEDURE (CYSTOSCOPY). THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND IT WAS FOUND THAT THE FORCEPS JAW/COMPONENT DISLODGED. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063386 ↗
• MalfunctionAug 30, 2022Break; Corroded; Break; Corroded

  CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR OF THE GRASPING PART OF THE DEVICE NOT OPENING AND CLOSING PROPERLY. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE WAS CORROSION FOREIGN MATERIAL ON THE FORCEPS AT THE DISTAL END. THE ARMS OF THE GRASPING JAWS (A PART OF THE LINKAGE MECHANISM AT THE DISTAL END) WERE BROKEN OFF. THE BROKEN SURFACE INDICATED BRITTLE FRACTURE DUE TO CORROSION. THE BROKEN ARM WAS MISSING. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE CORROSION FOREIGN MATERIAL FOUND ON THE FORCEPS DISTAL END AS OBSERVED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322870 ↗
• MalfunctionAug 4, 2022Device Reprocessing Problem; Contamination; Device Reprocessing Problem; Contamination

  THE CUSTOMER REPORTED TO OLYMPUS, DURING PREPARATION FOR USE FOR A UROLOGICAL PROCEDURE, THE GRASPING FORCEPS GRIP (JAW) WAS STIFF AND DID NOT OPEN. ANOTHER GRASPING FORCEPS WAS USED, HOWEVER, THE SAME ISSUE OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED BY SWITCHING TO A SPARE GRASPING FORCEPS. THE SURGICAL DELAY WAS LESS THAN FIVE (5) MINUTES. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA AS THE PROCEDURE WAS AN OUTPATIENT EXAMINATION. NO PATIENT INJURY REPORTED. THE PRIMARY CLEANING, ULTRASONIC CLEANING, LUBRICATION, AND STERILIZATION OF THE DEVICE WAS IMPLEMENTED ACCORDING TO THE RECOMMENDATIONS OF THE INSTRUCTION MANUAL. IN THE UROLOGY DEPARTMENT, THE SAME PHENOMENON HAD OCCURRED MULTIPLE TIMES IN THE PAST. HOWEVER, THE CUSTOMER DID NOT RECALL THE NUMBER OF OCCURRENCES OR DATES OF THE EVENTS. THE ONLY INFORMATION PROVIDED FOR THE PAST MULTIPLE EVENTS WAS THAT THE ISSUES OCCURRED DURING AN UNKNOWN DIAGNOSTIC PROCEDURE. THE GRASPING FORCEPS GRIP (JAW) WAS STIFF AND DID NOT OPEN. THE INTENDED PROCEDURE WAS COMPLETED BY SWITCHING TO A SPARE GRASPING FORCEPS. THE SURGICAL DELAY WAS LESS THAN FIVE (5) MINUTES. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA AS THE PROCEDURE WAS AN OUTPA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163857 ↗
• MalfunctionAug 4, 2022Device Reprocessing Problem; Contamination; Device Reprocessing Problem; Contamination

  THE CUSTOMER REPORTED TO OLYMPUS, DURING PREPARATION FOR USE FOR A UROLOGICAL PROCEDURE, THE GRASPING FORCEPS GRIP (JAW) WAS STIFF AND DID NOT OPEN. ANOTHER GRASPING FORCEPS WAS USED, HOWEVER, THE SAME ISSUE OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED BY SWITCHING TO A SPARE GRASPING FORCEPS. THE SURGICAL DELAY WAS LESS THAN FIVE (5) MINUTES. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA AS THE PROCEDURE WAS AN OUTPATIENT EXAMINATION. NO PATIENT INJURY REPORTED. THE PRIMARY CLEANING, ULTRASONIC CLEANING, LUBRICATION, AND STERILIZATION OF THE DEVICE WAS IMPLEMENTED ACCORDING TO THE RECOMMENDATIONS OF THE INSTRUCTION MANUAL. IN THE UROLOGY DEPARTMENT, THE SAME PHENOMENON HAD OCCURRED MULTIPLE TIMES IN THE PAST. HOWEVER, THE CUSTOMER DID NOT RECALL THE NUMBER OF OCCURRENCES OR DATES OF THE EVENTS. THE ONLY INFORMATION PROVIDED FOR THE PAST MULTIPLE EVENTS WAS THAT THE ISSUES OCCURRED DURING AN UNKNOWN DIAGNOSTIC PROCEDURE. THE GRASPING FORCEPS GRIP (JAW) WAS STIFF AND DID NOT OPEN. THE INTENDED PROCEDURE WAS COMPLETED BY SWITCHING TO A SPARE GRASPING FORCEPS. THE SURGICAL DELAY WAS LESS THAN FIVE (5) MINUTES. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA AS THE PROCEDURE WAS AN OUTPA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163719 ↗
• MalfunctionJul 29, 2022Device Handling Problem; Device Handling Problem

  UPON A CALL FROM THE FACILITY TO THE OLYMPUS CALL CENTER FOR AN INQUIRY ABOUT REPROCESSING, IT WAS INDICATED THAT THERE WAS A POSSIBILITY THE FACILITY DID NOT HAVE AN ULTRASOUND WASHER, WHICH COULD LEAD TO POTENTIAL HARM TO A PATIENT OR THE DEVICE. HOWEVER, NO HARM TO ANY PATIENT OR MALFUNCTION OF THE DEVICE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127883 ↗
• MalfunctionMay 26, 2022Break; Mechanical Problem; Break; Mechanical Problem

  CUSTOMER REPORTED AN ISSUE OF "DIFFICULT TO OPEN THIS NEWLY DELIVERED INSTRUMENT (FG-53SX-1) GRASPING FORCEPS". THE ISSUE FOUND ON MONITORING DURING PER-CUTANEOUS TRACHEOSTOMY PLACEMENT. ACCORDING TO THE REPORTER, SAME DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED VERY SMOOTHLY, MAXIMUM OF 60 SECONDS BRONCHOSCOPY TIME . CUSTOMER REPORTED NO CONSEQUENCES FOR THE PATIENT (LONGER ANESTHESIA, ADDITIONAL PROCEDURES OR MEDICINAL TREATMENT). THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. DEVICE EVALUATION FOUND ONE OF THE ARMS OF THE CUPS (A PART OF THE LINKING MECHANISM AT THE DISTAL END) WAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14503172 ↗
• MalfunctionApr 21, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING AN UNKNOWN THERAPEUTIC PROCEDURE THE DEVICE JAW CAME OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED BY USING A SIMILAR DEVICE. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166854 ↗
• MalfunctionMar 3, 2022Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING A PROCEDURE USING THE SUBJECT DEVICE THE FOLLOWING EVENT OCCURRED. THE OPERATOR NOTICED BEFORE THE OPERATOR INSERTED THE DEVICE INTO THE ENDOSCOPE THAT THE JAWS DID NOT OPEN. THE DEVICE WAS USED FOR THE SECOND TIME AFTER PURCHASE. THE JAWS WAS LESS THAN A YEAR AFTER PURCHASE. THE INTENDED PROCEDURE WAS POSTPONED. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. ON FEB. 7, 2022, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE JAWS DID NOT OPEN, AND THAT A FOREIGN SUBSTANCE HAD ADHERED TO THE LINK MECHANISM OF THE DEVICE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664420 ↗
• MalfunctionDec 19, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE SUBJECT DEVICE BROKE AFER ONLY 6 MONTHS OF USE. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE DISTRIBUTOR CONFIRMED THE FOLLOWING EVENT ON (B)(6) 2021 AND DETERMINED THAT IT WAS AN MEDICAL DEVICE REPORT (MDR) REPORTABLE EVENT. PART OF THE BROKEN ARM WAS MISSING. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13040512 ↗