Olympus WA22302DRecalls & reported problems

Summary

The FDA's MAUDE database contains 299 adverse event reports that list this exact device (DI 14042761051665), received between May 4, 2018 and Sep 30, 2026 — classified as 49 injuries, 250 malfunctions.

The most frequently reported specific device problem is “Break” (174 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. 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

Recent adverse event reports

The 25 most recent of 299 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fracture; Detachment of Device or Device Component

  It was reported that during a therapeutic hysteroscopic uterine lesion resection with diagnostic curettage, the distal end of the HF resection electrode fractured and dropped into the uterine cavity. It was immediately located and the fallen remnant was retrieved with a foreign body forceps. The reported event resulted in a procedural prolongation of less than 30 minutes. There were no reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952319 ↗
• MalfunctionAug 13, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50230385 ↗
• MalfunctionAug 3, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50118533 ↗
• MalfunctionJun 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOOP PORTION OF THE LOOP ELECTRODE (VIA THE SUBJECT DEVICE) FELL OFF INSIDE THE PATIENT AND WAS RETRIEVED. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANS CERVICAL RESECTION IN SALINE 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 25644551 ↗
• MalfunctionJun 23, 2026Deformation Due to Compressive Stress

  THE CUSTOMER REPORTED THAT THE ELECTRODE WAS SEVERELY BENT AND THE DISTAL END WAS DEVIATED FROM THE SHAFT AXIS DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS HF-RESECTION ELECTRODE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25597160 ↗
• MalfunctionJun 18, 2026Break

  THE CUSTOMER REPORTED THAT THE LOOP BROKE ON THE RESECTION ELECTRODE. THE ISSUE WAS FOUND DURING A THERAPEUTIC HYSTEROSCOPIC UTERINE FIBROID RESECTION AND WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553096 ↗
• MalfunctionJun 3, 2026Material Twisted/Bent

  THE CUSTOMER REPORTED THE LOOP ELECTRODE WAS BENT DURING INSPECTION FOR USE INVOLVING AN OLYMPUS HF-RESECTION ELECTRODE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376880 ↗
• MalfunctionMay 28, 2026Fracture

  IT WAS REPORTED THAT THE ELECTRIC CUTTING LOOP FRACTURED ON THE RESECTION ELECTRODE. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE AND WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25324913 ↗
• MalfunctionMay 15, 2026Material Fragmentation; Material Separation

  IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP WAS BROKEN OFF. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187002 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT THE ELECTRIC CUTTING LOOP HAD A FRACTURE ON THE RESECTION ELECTRODE. THE ISSUE WAS FOUND DURING A HYSTEROSCOPIC ELECTROSURGICAL RESECTION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176225 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT THE RESECTION ELECTRODE HAD BROKEN AND AN INCOMPLETE CUTTING LOOP WAS OBSERVED. THE ISSUE WAS FOUND DURING A PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166710 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP'S METAL RING CAME OFF; ONE SIDE OF THE METAL RING CAME APART. THE ISSUE OCCURRED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25160370 ↗
• MalfunctionMay 7, 2026Break

  THE CUSTOMER BURST AND BROKE THE DEVICE DURING A THERAPEUTIC PROCEDURE INVOLVING AN OLYMPUS HF-RESECTION ELECTRODE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113593 ↗
• MalfunctionMay 1, 2026Material Twisted/Bent

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE LOOP WAS DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057745 ↗
• MalfunctionApr 30, 2026Activation Failure

  IT WAS REPORTED THE RESECTION ELECTRODE WAS FOUND THAT BOTH THE DISTAL AND REAR ENDS OF THE ELECTRODE HAD TURNED BLACK, AND THE AREA WHERE IT CONNECTED TO THE HANDLE BECAME HOT. THE PROCEDURE WAS UNKNOWN AND THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25052591 ↗
• MalfunctionApr 28, 2026Material Deformation

  IT WAS REPORTED THAT THE RESECTION ELECTRODE HAD EXCESSIVE BENDING AT THE DISTAL TIP. THE ISSUE WAS FOUND DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE AND COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020975 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THE RESECTION ELECTRODE HAD FRACTURED. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009478 ↗
• MalfunctionApr 21, 2026Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24946222 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED, DURING THE BLADDER RESECTION PROCEDURE, THE HIGH FREQUENCY RESECTION ELECTRODE LOOP "WAS USED FOR 15 MINUTES, THEN FUSED AND FRACTURED. THEN, A NEW LOOP WAS USED; AFTER 5 MINUTES, IT WAS AGAIN FUSED AND FRACTURED. THE ELECTRIC RESECTION WAS SET AT 280 DURING THE PROCEDURE. THE DEVICE WAS REPLACED TO CONTINUE THE PROCEDURE, AND IT DID NOT HAVE ANY IMPACTS ON THE PATIENT." (DEVICE 1 OF 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24946015 ↗
• MalfunctionApr 21, 2026Melted

  IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP METAL WAS MELTING. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945600 ↗
• MalfunctionApr 20, 2026Melted

  IT WAS REPORTED THE HF-RESECTION ELECTRODE WAS MELTED. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933725 ↗
• MalfunctionApr 19, 2026Fracture

  IT WAS REPORTED THE HF-RESECTION ELECTRIC CUTTING LOOP WAS MELTED AND FRACTURED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921283 ↗
• MalfunctionApr 17, 2026Break; Thermal Decomposition of Device

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24914256 ↗
• MalfunctionApr 15, 2026Fracture

  IT WAS REPORTED THE RESECTION ELECTRODE, THE NEWLY INSTALLED ELECTRIC CUTTING LOOP HAD MELTED AND FRACTURED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888989 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THE HIGH FREQUENCY-RESECTION ELECTRODE CUTTING LOOP FRACTURED DURING A LAPAROSCOPIC AND HYSTEROSCOPIC MYOMECTOMY. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766706 ↗