PENTAX KW1818CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04961333224463), received between Jul 24, 2021 and Aug 6, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2021Difficult to Open or Close; Difficult to Open or Close

  THE FORCEPS MAY OR MAY NOT OPEN AFTER THE HANDLE OPERATION. (WHEN CONFIRMING AT THE HOSPITAL, CONFIRM THAT IT WILL OPEN IN ABOUT 1 SECOND) .AS A RESULT OF CHECKING, THERE WAS A CATCH WHEN OPERATING ON THE OPENING SIDE, AND THERE WAS A TIME LAG BETWEEN WHEN THE HANDLE WAS OPERATED AND WHEN IT WAS OPENED. IN ADDITION, SINCE DEFECTS WERE CONFIRMED IN THE PRE-USE INSPECTION, NO HEALTH DAMAGE HAS OCCURRED TO PATIENTS OR MEDICAL STAFF. IT IS THE SAME DEVICE INVOLVED IN FIVE DIFFERENT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285963 ↗
• MalfunctionAug 6, 2021Difficult to Open or Close; Difficult to Open or Close

  THE FORCEPS MAY OR MAY NOT OPEN AFTER THE HANDLE OPERATION. (WHEN CONFIRMING AT THE HOSPITAL, CONFIRM THAT IT WILL OPEN IN ABOUT 1 SECOND) AS A RESULT OF CHECKING, THERE WAS A CATCH WHEN OPERATING ON THE OPENING SIDE, AND THERE WAS A TIME LAG BETWEEN WHEN THE HANDLE WAS OPERATED AND WHEN IT WAS OPENED. IN ADDITION, SINCE DEFECTS WERE CONFIRMED IN THE PRE-USE INSPECTION, NO HEALTH DAMAGE HAS OCCURRED TO PATIENTS OR MEDICAL STAFF. IT IS THE SAME DEVICE INVOLVED IN FIVE DIFFERENT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285962 ↗
• MalfunctionAug 6, 2021Difficult to Open or Close; Difficult to Open or Close

  THE FORCEPS MAY OR MAY NOT OPEN AFTER THE HANDLE OPERATION. (WHEN CONFIRMING AT THE HOSPITAL, CONFIRM THAT IT WILL OPEN IN ABOUT 1 SECOND). AS A RESULT OF CHECKING, THERE WAS A CATCH WHEN OPERATING ON THE OPENING SIDE, AND THERE WAS A TIME LAG BETWEEN WHEN THE HANDLE WAS OPERATED AND WHEN IT WAS OPENED. IN ADDITION, SINCE DEFECTS WERE CONFIRMED IN THE PRE-USE INSPECTION, NO HEALTH DAMAGE HAS OCCURRED TO PATIENTS OR MEDICAL STAFF. IT IS THE SAME DEVICE INVOLVED IN FIVE DIFFERENT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285961 ↗
• MalfunctionAug 6, 2021Difficult to Open or Close; Difficult to Open or Close

  THE FORCEPS MAY OR MAY NOT OPEN AFTER THE HANDLE OPERATION. (WHEN CONFIRMING AT THE HOSPITAL, CONFIRM THAT IT WILL OPEN IN ABOUT 1 SECOND) AS A RESULT OF CHECKING, THERE WAS A CATCH WHEN OPERATING ON THE OPENING SIDE, AND THERE WAS A TIME LAG BETWEEN WHEN THE HANDLE WAS OPERATED AND WHEN IT WAS OPENED. IN ADDITION, SINCE DEFECTS WERE CONFIRMED IN THE PRE-USE INSPECTION, NO HEALTH DAMAGE HAS OCCURRED TO PATIENTS OR MEDICAL STAFF. IT IS THE SAME DEVICE INVOLVED IN FIVE DIFFERENT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285958 ↗
• MalfunctionAug 6, 2021Difficult to Open or Close; Difficult to Open or Close

  THE FORCEPS MAY OR MAY NOT OPEN AFTER THE HANDLE OPERATION. (WHEN CONFIRMING AT THE HOSPITAL, CONFIRM THAT IT WILL OPEN IN ABOUT 1 SECOND). AS A RESULT OF CHECKING, THERE WAS A CATCH WHEN OPERATING ON THE OPENING SIDE, AND THERE WAS A TIME LAG BETWEEN WHEN THE HANDLE WAS OPERATED AND WHEN IT WAS OPENED. IN ADDITION, SINCE DEFECTS WERE CONFIRMED IN THE PRE-USE INSPECTION, NO HEALTH DAMAGE HAS OCCURRED TO PATIENTS OR MEDICAL STAFF. IT IS THE SAME DEVICE INVOLVED IN FIVE DIFFERENT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285957 ↗
• MalfunctionJul 30, 2021Material Deformation; Material Deformation

  THERE WAS NO REPORT OF PATIENT HARM. WHEN THE OPERATION WAS CHECKED BY STERILIZATION BEFORE USE, THE CUP DID NOT OPEN. IT COULD NOT BE USED IN THE INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250859 ↗
• MalfunctionJul 24, 2021Unintended Movement; Unintended Movement

  THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. I OPENED THE BIOPSY FORCEPS KW1818CS PURCHASED IN 2019 FOR THE FIRST TIME LAST WEEK AND USED IT ONLY A FEW TIMES, BUT SOMETIMES IT DOESN'T OPEN THE CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222569 ↗
• MalfunctionJul 24, 2021Unintended Movement; Unintended Movement

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. WHEN I CHECKED THE OPERATION WITH STERILIZATION BEFORE USE, THE CUP DID NOT OPEN. CANNOT BE USED FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222497 ↗