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Olympus A22202CRecalls & 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
8
Deaths reported
0
Injuries reported
2
Recalls naming it
1

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 14042761036662), received between Oct 22, 2020 and Jan 29, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

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: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 3 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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

  • Break8
  • Entrapment of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Device Embedded In Tissue or Plaque1
  • Foreign Body In Patient1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 29, 2026Break

    IT WAS REPORTED THE RESECTION ELECTRODE LOOP BROKE HAD BROKEN. THE ISSUE WAS FOUND DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24218185 ↗
  • MalfunctionJan 6, 2026Break

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23976154 ↗
  • MalfunctionJan 5, 2026Break

    IT WAS REPORTED THE HF-RESECTION ELECTRODE HAD AN ELECTRODE LOOP BREAK DURING A TRANSURETHRAL RESECTION OF THE PROSTATE. THIS PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23966725 ↗
  • MalfunctionMay 27, 2025Break; Break

    IT WAS REPORTED THAT THE ELECTRODE LOOP BROKE ON THE PROBE. THE ISSUE OCCURRED DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22092993 ↗
  • MalfunctionMay 27, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22092874 ↗
  • InjuryOct 21, 2022Break; Break

    OLYMPUS RECEIVED A MEDWATCH REPORT (MW5111906) REPORTING THE FOLLOWING EVENT: DURING A CYSTOSCOPY FOR A TRANSURETHRAL RESECTION OF THE PROSTATE, FULGURATION OF BLEEDING SITES AND EVACUATION OF CLOTS WITH THE SUBJECT DEVICE, AFTER RESECTION, THE LOOP WAS MISSING FROM THE SHAFT OF THE SUBJECT DEVICE ELECTRODE. THE LOOP WAS NOT LOCATED IN THE URINARY SURGICAL AREA, IN THE IRRIGATION FLUID OR ON THE STERILE FIELD. DURING THE CASE, 28, 000 MLS OF FLUID WAS USED. THE SURGEON REPORTED THE LOOP WAS EITHER FLUSHED OUT WITH THE COPIOUS AMOUNTS OF IRRIGATION OR DISINTEGRATED DUE TO THE HEAT DURING USE OF THE DEVICE. THE VENDOR REPRESENTATIVE CONFIRMED THIS POSSIBLE CAUSE. SURGEON WAS INFORMED THE DEVICE BROKE AND WAS EITHER FRAGMENTED OR DETERIORATED AND NOT RETRIEVABLE AND WAS LARGER THAN A 10MM NEEDLE, AN X-RAY WAS REQUIRED TO LOCATE THE FRAGMENT PER FACILITY POLICY. DUE DILIGENCE WAS DONE TO LOCATE THE FRAGMENTED LOOP USING A CAMERA AND MONITOR AT THE END OF THE PROCEDURE AND THE BROKEN DEVICE WAS NOT IDENTIFIED. IN ADDITION THE PATIENT HAD CONTINUOUS IRRIGATION POST-OPERATIVELY. A POST-OPERATIVE KIDNEY, URETERS, BLADDER (KUB) X-RAY WAS PERFORMED AND THE METALLIC FRAGMENT WAS IDENTIFIED IN

    Patient problems: Foreign Body In Patient

    MAUDE report 15650557 ↗
  • InjuryOct 21, 2022Break; Entrapment of Device

    OLYMPUS RECEIVED A MEDWATCH REPORT (MW5111906) REPORTING THE FOLLOWING EVENT: DURING A CYSTOSCOPY FOR A TRANSURETHRAL RESECTION OF THE PROSTATE, FULGURATION OF BLEEDING SITES AND EVACUATION OF CLOTS WITH THE SUBJECT DEVICE, AFTER RESECTION, THE LOOP WAS MISSING FROM THE SHAFT OF THE SUBJECT DEVICE ELECTRODE. THE LOOP WAS NOT LOCATED IN THE URINARY SURGICAL AREA, IN THE IRRIGATION FLUID OR ON THE STERILE FIELD. DURING THE CASE, 28, 000 MLS OF FLUID WAS USED. THE SURGEON REPORTED THE LOOP WAS EITHER FLUSHED OUT WITH THE COPIOUS AMOUNTS OF IRRIGATION OR DISINTEGRATED DUE TO THE HEAT DURING USE OF THE DEVICE. THE VENDOR REPRESENTATIVE CONFIRMED THIS POSSIBLE CAUSE. SURGEON WAS INFORMED THE DEVICE BROKE AND WAS EITHER FRAGMENTED OR DETERIORATED AND NOT RETRIEVABLE AND WAS LARGER THAN A 10MM NEEDLE, AN X-RAY WAS REQUIRED TO LOCATE THE FRAGMENT PER FACILITY POLICY. DUE DILIGENCE WAS DONE TO LOCATE THE FRAGMENTED LOOP USING A CAMERA AND MONITOR AT THE END OF THE PROCEDURE AND THE BROKEN DEVICE WAS NOT IDENTIFIED. IN ADDITION THE PATIENT HAD CONTINUOUS IRRIGATION POST-OPERATIVELY. A POST-OPERATIVE KIDNEY, URETERS, BLADDER (KUB) X-RAY WAS PERFORMED AND THE METALLIC FRAGMENT WAS IDENTIFIED IN

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 15650472 ↗
  • MalfunctionOct 22, 2020Break; Break

    OLYMPUS RECEIVED A MEDWATCH ((B)(4)) FROM THE FDA VIA MAIL. THE MEDWATCH STATES THAT "DURING THE PROCEDURE THE SURGEON STATED THE RESECTOSCOPE LOOP BROKE OFF IN THE PATIENT." THE DATE OF EVENT WAS IN(B)(6) 2020. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10719049 ↗

Other Unit, Electrosurgical, Endoscopic (With Or Without Accessories) devices

All Unit, Electrosurgical, Endoscopic (With Or Without Accessories) devices →

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