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Olympus WA22607DRecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14042761075487), received between Mar 8, 2019 and Mar 8, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 8, 2023Open, Classified

    Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

    Z-2413-2023 · Root cause: Process design · FDA record ↗

Most reported problems

Device problems

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 8, 2019Break; Break

    OLYMPUS RECEIVED A MEDWATCH (REPORT# (B)(4)), WHICH STATED THAT WHILE THE DOCTOR WAS PERFORMING A TURP AND USING THE BUTTON TURP LOOP, THE LOOP BROKE WHILE CAUTERIZING THE PROSTATE. THE ENDS OF THE LOOP CURLED UP. THE ENTIRE LOOP IS STILL THERE, IT JUST CURLED UP AT THE ENDS. A NEW LOOP WAS OBTAINED AND THE PROCEDURE CONTINUED WITH NO HARM TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8405938 ↗

Other Electrode, Electrosurgical, Active, Urological devices

All Electrode, Electrosurgical, Active, Urological devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.