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