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Olympus WA69370MRecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Jaws insert "HICURA", 5 x 330, Metzenbaum, monopolar · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761079761), received between Aug 28, 2023 and Jun 19, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 2 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component2
  • Break1
  • Connection Problem1
  • Difficult to Open or Close1
  • Material Split, Cut or Torn1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 19, 2026Material Split, Cut or Torn

    THE CUSTOMER RETURNED THE RIGID ENDOSCOPIC SCISSORS TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE FIELD SERVICE ENGINEER IDENTIFIED THE BREAKAGE OR LOSS OF DISTAL COMPONENTS OF THE JAW. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25565670 ↗
  • MalfunctionFeb 24, 2025Break; Break

    IT WAS REPORTED THAT DURING REPROCESSING, THE BASE SECTION OF THE UNIT WAS BROKEN AT THE ASSEMBLY PART OF THE UNIT AND HANDLE WHEN THE ASSEMBLY WORK WAS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21446893 ↗
  • MalfunctionFeb 21, 2025Mechanical Problem; Mechanical Problem

    IT WAS REPORTED HICURA JAWS INSERT SCISSORS NOT OPENED. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21437294 ↗
  • MalfunctionJul 15, 2024Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED, WHEN OPENING AND CLOSING THE MONOPOLAR JAWS INSERT THE TIP OF THE SCISSOR¿S FORCEPS UNIT DID NOT OPEN WHEN THE HANDLE WAS GRIPPED. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A THERAPEUTIC LAPACOLLE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19744159 ↗
  • MalfunctionSep 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT WHEN USING A SHAFT ¿HICURA¿, 5 X 330, MONOPOLAR, THE SHAFT (THE BALL AT THE DISTAL END OF THE INLAY) DETACHED FROM THE HANDLE, AND THE SHAFT AND INLAY COULD NOT BE REMOVED FROM THE TROCAR. THE USER THEN CLOSED THE BRANCHES OF THE SCISSORS FROM ANOTHER TROCAR WITH PLIERS TO REMOVE THE INLAY AND PIPE SHAFT. THE EVENT OCCURRED DURING THE THERAPEUTIC (LAPAROSCOPIC) PROCEDURE AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE REPORT IS LINKED TO PATIENT IDENTIFIERS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17710109 ↗
  • MalfunctionSep 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    THE ISSUE WAS FOUND DURING A THERAPEUTIC, LAPAROSCOPIC PROCEDURE. THE PROCEDURE EXPERIENCED AN UNKNOWN DELAY DUE TO THE SHEARING INLAY NEEDED TO BE RECOVERED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17696078 ↗
  • MalfunctionAug 28, 2023Connection Problem; Connection Problem

    THE CUSTOMER REPORTED THAT HIS OLYMPUS HICURA SCISSORS WERE EXPERIENCING A CONNECTION ISSUE. ACCORDING TO THE INITIAL REPORTER, SHAFT DETACHES FROM THE HANDLE AND THEN THE SHAFT INLAY. AS THIS OCCURS ONCE THE BRANCHERS ARE SPREAD, THE DEVICE CANNOT BE REMOVED FROM THE TROCAR. REPORTEDLY, THE SURGEON USED A PAIR OF PLIERS TO CLOSE THE BRANCHES OF THE HICURA DEVICE, AND THEN REMOVED THE INLAY AND PIPE SHAFT. THE CUSTOMER DID GO ON TO NOTE THAT THIS EVENT HAS OCCURRED ¿REPEATEDLY¿. PLEASE SEE REPORT WITH PATIENT IDENTIFIER (B)(6) FOR RELATED INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17632130 ↗

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Sources and updates

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