Single Use Grasping Forceps FG-253SXRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04953170412059), received between Jul 7, 2023 and Jun 10, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (13 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.

• MalfunctionJun 10, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176835 ↗
• MalfunctionFeb 20, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS DIFFICULTY OPENING THE PACKAGING FOR THE GRASPING FORCEPS. THE TOP LAYER WAS TORN, CONTAMINATING THE CONTENTS. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A THERAPEUTIC LITHOTRIPSY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421966 ↗
• MalfunctionFeb 20, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS DIFFICULTY OPENING THE PACKAGING FOR THE GRASPING FORCEPS. THE TOP LAYER WAS TORN, CONTAMINATING THE CONTENTS. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A THERAPEUTIC LITHOTRIPSY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421964 ↗
• MalfunctionJan 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED A PACKAGING DEFECT CAUSED THE FORCEPS STERILITY TO BE COMPROMISED. THE ISSUE OCCURRED DURING A DIAGNOSTIC URETEROSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160015 ↗
• MalfunctionAug 14, 2024Problem with Sterilization; Problem with Sterilization

  IT WAS REPORTED THAT THE GRASPING FORCEP'S PACKAGING WAS POOR, AND THE CLEAR FILM FREQUENTLY TORE, COMPROMISING STERILITY. THE ISSUE OCCURRED DURING PREPARATION OF USE OF A THERAPEUTIC CYSTO STENT REMOVAL PROCEDURE. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986542 ↗
• MalfunctionJul 24, 2024Contamination; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Contamination; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE GRASPING FORCEPS PACKAGE WAS DIFFICULT TO OPEN. THE TOP LAYER WAS TORN AND THE CONTENTS WERE CONTAMINATED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821886 ↗
• MalfunctionFeb 28, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED, THAT THE SINGLE USE GRASPING FORCEPS, WOULD TEAR A HOLE IN PACKAGING WHEN OPENING ON TO A STERILE FIELD. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM. ANOTHER RELATED COMPLAINT WAS CREATED TO COVER THE POSSIBILITY OF MORE THAN ONE EVENT UNDER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803346 ↗
• MalfunctionFeb 27, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DISPOSABLE GRASPING FORCEPS TORE A HOLE IN THE PACKAGING WHEN OPENING IN A STERILE FIELD. THERE WAS A FEW OF THE GRASPERS BEING PREPPED THAN THE ONE PACKAGE INVOLVED. THE ISSUE OCCURRED DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790037 ↗
• MalfunctionDec 21, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC REMOVAL OF URETERAL STENT PROCEDURE THE SINGLE USE GRASPING FORCEPS DID NOT COME OUT OF THE PACKAGE AND REMAINED STERILE. THE PLASTIC SIDE OF THE PACKAGE RIPPED AND TORN AND CONTAMINATED THE INNER ITEM, RENDERING IT UNUSABLE. STAFF REPORTED THAT THAT HAD BEEN HAPPENING MORE THAN THESE TWO TIMES. THE PROCEDURE WAS COMPLETED, BUT IT WAS SLOWED DOWN BY HAVING TO OPEN A NEW GRASPER. THERE WAS NO REPORT ON PATIENT HARM ASSOCIATED WITH THE EVENT. CUSTOMER DID NOT HAVE ANY OTHER PACKAGING. THOSE DISPOSABLE GRASPERS WERE THE ONLY OPTION CUSTOMER WAS HAVING FOR REMOVING/CHANGING URETERAL STENTS. CUSTOMER HAD THOSE 2 UNUSABLE ONES DUE TO POOR/DEFECTIVE PACKAGING. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380062 ↗
• MalfunctionDec 20, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED TO OLYMPUS, THE GRASPING FORCEPS PACKAGING WOULD RIP AND TEAR ON THE PLASTIC SIDE AND CONTAMINATE THE INNER ITEM RENDERING IT UNUSABLE. THE ISSUE WAS FOUND DURING A THERAPEUTIC UROLOGY PROCEDURE. THE PROCEDURE WAS HINDERED BY HAVING TO OPEN ANOTHER GRASPER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366972 ↗
• MalfunctionNov 7, 2023Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  AN OLYMPUS SENIOR SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT TWO SINGLE USE GRASPING FORCEPS FG-253SX HAD PACKAGING PROBLEMS. THE INITIAL PACKAGE WAS TOO FLIMSY / SEALED TOO TIGHTLY. IT WOULD ONLY RIP INTO TINY PIECES AND THE GRASPER BECAME CONTAMINATED AND THE SECOND GRASPER HAD THE SAME ISSUE. HOWEVER, THEY WERE ABLE TO USE IT. THE ISSUE WAS FOUND DURING A THERAPEUTIC STENT REMOVAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088378 ↗
• MalfunctionNov 5, 2023Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  THE OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT UPON OPENING THE PACKAGE TO USE, IT WOULD ONLY RIP INTO TINY PIECES AND THE GRASPER BECAME CONTAMINATED ON THE SINGLE USE GRASPING FORCEPS FG-253SX DURING THE THERAPEUTIC STENT REMOVAL PROCEDURE. THE 2ND GRASPER HAD THE SAME ISSUE; HOWEVER, THEY WERE ABLE TO USE IT. THE 2ND GRASPER HAD THE SAME PACKAGING ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE ISSUE REPORTED DID NOT IMPACT THE OUTCOME OF THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS LINKED TO PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070801 ↗
• MalfunctionOct 16, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  THE CUSTOMER REPORTED THE SINGLE USE GRASPING FORCEPS WERE USED DURING A STENT REMOVAL PROCEDURE. THE CUSTOMER REPORTED THE UNIT PACKAGE WAS NOT OPENING EASILY. WHEN THE PACKAGE WAS OPENED, SMALL PAPER FIBERS AND PLASTIC SHREDS FROM THE PACKAGING HAD COME OFF WHICH CONTAMINATED THE INSTRUMENTS. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17945659 ↗
• MalfunctionOct 6, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  A CUSTOMER SUBMITTED A MEDICAL DEVICE INCIDENT OR PROBLEM REPORT (MDIP) TO AHS (ALBERTA HEALTH SERVICES) STATING THE SINGLE USE GRASPING FORCEPS STERILE PACKAGING WAS VERY DIFFICULT TO OPEN. THE PAPER WAS RIPPING WHILE OPENING, CAUSING THE STERILE ITEM TO BECOME CONTAMINATED BEFORE USE. WHILE ATTEMPTING TO OPEN THE FIRST UNIT, THE PACKAGING RIPPED. WHEN THE SECOND UNIT WAS BEING OPENED, THE PACKAGING RIPPED AGAIN, BUT WAS ABLE TO BE OPENED IN A STERILE MANNER AND USED FOR THE SURGICAL PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE CUSTOMER DOUBLE CHECKED TO CONFIRM THE PACKAGING WAS BEING OPENED IN THE CORRECT ORIENTATION. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17889351 ↗
• MalfunctionOct 6, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  A CUSTOMER SUBMITTED A MEDICAL DEVICE INCIDENT OR PROBLEM REPORT (MDIP) TO AHS (ALBERTA HEALTH SERVICES) STATING THE SINGLE USE GRASPING FORCEPS STERILE PACKAGING WAS VERY DIFFICULT TO OPEN. THE PAPER WAS RIPPING WHILE OPENING, CAUSING THE STERILE ITEM TO BECOME CONTAMINATED BEFORE USE. WHILE ATTEMPTING TO OPEN THE FIRST UNIT, THE PACKAGING RIPPED. WHEN THE SECOND UNIT WAS BEING OPENED, THE PACKAGING RIPPED AGAIN, BUT WAS ABLE TO BE OPENED IN A STERILE MANNER AND USED FOR THE SURGICAL PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE CUSTOMER DOUBLE CHECKED TO CONFIRM THE PACKAGING WAS BEING OPENED IN THE CORRECT ORIENTATION. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17888510 ↗
• MalfunctionSep 26, 2023Contamination; Packaging Problem; Contamination; Packaging Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT ON THE SINGLE USE GRASPING FORCEPS FG-253SX THEY TRIED TO OPEN STERILE PACKAGING HOWEVER THE PACKAGE RIPPED/PEELED POORLY, AND THE INSIDE PRODUCT WAS CONTAMINATED DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821623 ↗
• MalfunctionSep 20, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TEARED WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778907 ↗
• MalfunctionSep 20, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TEARED WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778884 ↗
• MalfunctionSep 20, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TEARED WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6) AND (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778823 ↗
• MalfunctionSep 20, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TEARED WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778775 ↗
• MalfunctionSep 20, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TEARED WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778764 ↗
• MalfunctionSep 20, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TEARED WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778754 ↗
• MalfunctionSep 20, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TEARED WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778734 ↗
• MalfunctionSep 20, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TORE WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778696 ↗
• MalfunctionSep 20, 2023Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS TIGHT ON THE PRODUCT AND TEARED WHEN TRYING TO OPEN IT COMPROMISING STERILITY ON THE SURGICAL FIELD¿. PER THE REPORT, THERE ARE 10 DEFECTIVE PRODUCTS (SAME ISSUE ) MODEL AND LOT NUMBER - SINGLE USE GRASPING FORCEPS FG-253SX, LOT NUMBER: 37K). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778649 ↗