Forceps/Irrigation Plug (Isolated Type) MAJ-891Recalls & reported problems

Summary

The FDA's MAUDE database contains 257 adverse event reports that list this exact device (DI 04953170063114), received between Dec 15, 2020 and Jul 14, 2025 — classified as 1 death, 159 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (86 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 18, 2024Open, Classified

   Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.

   Z-0905-2025 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 257 reports, in the reporter's own words as published by the FDA.

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

  CORRECTION TO B5 FOR INFORMATION INADVERTENTLY LEFT OUT OF PREVIOUS REPORT: IT WAS REPORTED BY THE ENDOSCOPIC SUPPORT SPECIALIST (ESS) THAT THE CUSTOMER DISASSEMBLED THE FORCEPS IRRIGATION PLUG INTO THREE PARTS INSTEAD OF FOUR PARTS DURING REPROCESSING. THE ISSUE WAS IDENTIFIED DURING A REPROCESSING IN-SERVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494797 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS MISSING THE BLACK CAPS. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22476251 ↗
• InjuryJul 9, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THREE PATIENTS PRESENTED WITH SEPSIS AFTER PROCEDURES USING A CYSTO-NEPHRO VIDEOSCOPE WITH FORCEPS/IRRIGATION PLUG DEVICES. NO ADDITIONAL RELEVANT CLINICAL INFORMATION WAS PROVIDED BY THE REPORTER. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS.

  Patient problems: Sepsis

  MAUDE report 22464253 ↗
• InjuryJul 9, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THREE PATIENTS PRESENTED WITH SEPSIS AFTER PROCEDURES USING A CYSTO-NEPHRO VIDEOSCOPE WITH FORCEPS/IRRIGATION PLUG DEVICES. NO ADDITIONAL RELEVANT CLINICAL INFORMATION WAS PROVIDED BY THE REPORTER. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: Sepsis

  MAUDE report 22464226 ↗
• InjuryJul 9, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THREE PATIENTS PRESENTED WITH SEPSIS AFTER PROCEDURES USING A CYSTO-NEPHRO VIDEOSCOPE WITH FORCEPS/IRRIGATION PLUG DEVICES. NO ADDITIONAL RELEVANT CLINICAL INFORMATION WAS PROVIDED BY THE REPORTER. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS.

  Patient problems: Sepsis

  MAUDE report 22463456 ↗
• InjuryJul 9, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THREE PATIENTS PRESENTED WITH SEPSIS AFTER PROCEDURES USING A CYSTO-NEPHRO VIDEOSCOPE WITH FORCEPS/IRRIGATION PLUG DEVICES. NO ADDITIONAL RELEVANT CLINICAL INFORMATION WAS PROVIDED BY THE REPORTER. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: Sepsis

  MAUDE report 22463033 ↗
• InjuryJul 9, 2025Device Reprocessing Problem; Device Reprocessing Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Sepsis

  MAUDE report 22462745 ↗
• InjuryJul 9, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THREE PATIENTS PRESENTED WITH SEPSIS AFTER PROCEDURES USING A CYSTO-NEPHRO VIDEOSCOPE WITH FORCEPS/IRRIGATION PLUG DEVICES. NO ADDITIONAL RELEVANT CLINICAL INFORMATION WAS PROVIDED BY THE REPORTER. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: Sepsis

  MAUDE report 22462623 ↗
• MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334939 ↗
• MalfunctionMar 17, 2025Failure to Clean Adequately; Failure to Clean Adequately

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617820 ↗
• MalfunctionMar 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546846 ↗
• MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE CYSTO-NEPHRO VIDEOSCOPE WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Bacterial Infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456132 ↗
• MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE FORCEPS/IRRIGATION PLUG ACCESSORY WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456087 ↗
• MalfunctionOct 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE FORCEPS/IRRIGATION PLUG ACCESSORY WAS INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20454841 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE FORCEPS/IRRIGATION PLUG WAS INCORRECTLY REPROCESSED. THE FACILITY WAS INTERVIEWED BY THE OLYMPUS REPRESENTATIVES AND STATED DEVIATION FROM THE REPROCESSING GUIDELINES. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT AND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434388 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE FORCEPS/IRRIGATION PLUG WAS INCORRECTLY REPROCESSED. THE FACILITY WAS INTERVIEWED BY THE OLYMPUS REPRESENTATIVES AND STATED DEVIATION FROM THE REPROCESSING GUIDELINES. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT AND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434243 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE FORCEPS/IRRIGATION PLUG WAS INCORRECTLY REPROCESSED. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434021 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE FORCEPS/IRRIGATION PLUG WAS INCORRECTLY REPROCESSED. THE FACILITY WAS INTERVIEWED BY THE OLYMPUS REPRESENTATIVES AND STATED DEVIATION FROM THE REPROCESSING GUIDELINES. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT AND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433512 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE FORCEPS/IRRIGATION PLUG WAS INCORRECTLY REPROCESSED. THE FACILITY WAS INTERVIEWED BY THE OLYMPUS REPRESENTATIVES AND STATED DEVIATION FROM THE REPROCESSING GUIDELINES. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT AND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433507 ↗
• MalfunctionOct 11, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE FORCEPS/IRRIGATION PLUG WAS INCORRECTLY REPROCESSED. THE FACILITY WAS INTERVIEWED BY THE OLYMPUS REPRESENTATIVES AND STATED DEVIATION FROM THE REPROCESSING GUIDELINES. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT AND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433496 ↗
• MalfunctionOct 9, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT PEELING HAD OCCURRED ON THE INSIDE OF FORCEPS/IRRIGATION PLUG. IT WAS NOTED THAT PARTS HAD FALLEN OFF. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407626 ↗
• MalfunctionOct 8, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE FORCEPS/IRRIGATION PLUG DISASSEMBLING, CLEANING, DISINFECTING, AND THE FORCEPS STOPPER REPLACEMENT WERE NOT DONE AS DESCRIBED IN THE INSTRUCTION MANUAL LEADING TO DETERIORATION WITH USE. THE ISSUE OCCURRED DURING REPROCESSING. NO HEALTH HAZARDS HAVE BEEN REPORTED AS A RESULT OF THIS INCIDENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20399414 ↗
• MalfunctionOct 8, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE FORCEPS/IRRIGATION PLUG DISASSEMBLING, CLEANING, DISINFECTING, AND THE FORCEPS STOPPER REPLACEMENT WERE NOT DONE AS DESCRIBED IN THE INSTRUCTION MANUAL LEADING TO DETERIORATION WITH USE. THE ISSUE OCCURRED DURING REPROCESSING. NO HEALTH HAZARDS HAVE BEEN REPORTED AS A RESULT OF THIS INCIDENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397184 ↗
• MalfunctionOct 8, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE FORCEPS/IRRIGATION PLUG WAS NOT DISASSEMBLED, CLEANED, AND DISINFECTED AS DESCRIBED IN THE INSTRUCTION MANUAL. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395978 ↗
• MalfunctionSep 18, 2024Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS WAS INFORMED THAT DURING A DEMONSTRATION AND USE OF FORCEPS/IRRIGATION PLUG (ISOLATED TYPE), THE USER FACILITY STERILIZED THE DEVICE USING STERAD STERILIZATION PROCESS WITHOUT PROPER STERILIZATION SPECIFICATIONS. NO PATIENT INFECTIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244892 ↗