Olympus A22251CRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 14042761036815), received between Jul 12, 2018 and Jan 29, 2024 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE ROLLER BALL PORTION OF THE HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30° FELL OFF INTO THE PATIENT DURING A THERAPEUTIC HYSTEROSCOPY WITH DILATATION & CURETTAGE AND ENDOMETRIAL ABLATION. A VAGINAL EXAM WAS PERFORMED TO LOOK FOR AND RETRIEVE THE ROLLER BALL CAUSING PROLONGATION OF THE PROCEDURE FOR AN UNSPECIFIED DURATION. THE PATIENT'S ANESTHESIA WAS EXTENDED BY A FEW MINUTES. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596937 ↗
• InjuryJan 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE ROLLER BALL PORTION OF THE HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30° FELL OFF INTO THE PATIENT DURING A THERAPEUTIC HYSTEROSCOPY WITH DILATATION & CURETTAGE AND ENDOMETRIAL ABLATION. A VAGINAL EXAM WAS PERFORMED TO LOOK FOR AND RETRIEVE THE ROLLER BALL CAUSING PROLONGATION OF THE PROCEDURE FOR AN UNSPECIFIED DURATION. THE PATIENT'S ANESTHESIA WAS EXTENDED BY A FEW MINUTES. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596852 ↗
• InjuryDec 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE, ON BEHALF OF THE CUSTOMER, REPORTED TO OLYMPUS THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE, THE MONOPOLAR ROLLERBALL OF THE HF-RESECTION ELECTRODE BROKE OFF IN PATIENT. DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DEVICE AND EVENT, NONE WAS OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18247726 ↗
• InjuryDec 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE, ON BEHALF OF THE CUSTOMER, REPORTED TO OLYMPUS THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE, THE MONOPOLAR ROLLERBALL OF THE HF-RESECTION ELECTRODE BROKE OFF IN PATIENT. DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DEVICE AND EVENT, NONE WAS OBTAINED. D1, FULL NAME OF DEVICE: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE, 12 PCS.

  Patient problems: Foreign Body In Patient

  MAUDE report 18247565 ↗
• InjuryJul 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR, THE ELECTRODE BALL WAS NOTED TO BE MISSING AND HAD COME OFF THE WHOLE ELECTRODE. THE PHYSICIAN CHECKED THE BLADDER AND URETHRA FOR THE FOREIGN BODY. IT WAS NOTED THE DEVICE HAD COME OUT OF THE THIRD-PARTY SUCTION TUBING. NO X-RAY WAS DONE TO CONFIRM AS THE SURGEON WAS COMFORTABLE THAT THE DEVICE HAD BEEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS PROLONGED BY 10 TO 15 MINUTES. NO ADDITIONAL TREATMENT WAS REQUIRED. THE PATIENT IS IN RECOVERY WITH NO ISSUES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313038 ↗
• MalfunctionNov 18, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE AT AN UNKNOWN DATE, THE ROLLER BALL AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834636 ↗
• MalfunctionNov 18, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE ROLLER BALL AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834590 ↗
• InjuryFeb 11, 2021Melted; Material Separation; Melted; Material Separation

  IT IS REPORTED DURING AN ABLATION RESECTION IN THE UTERUS USING A HF-RESECTION ELECTRODE (ROLLER), THE ROLLERBALL TIP BROKE, BURNT OUT AND BECAME DAMAGED. THE PROCEDURE WAS COMPLETED. THE ISSUE WITH THE DEVICE DID NOT IMPACT THE OUTCOME OF THE PROCEDURE. X-RAY PERFORMED AFTER THE PROCEDURE SHOWED THE DEVICE FRAGMENT REMAINS INSIDE THE PATIENT. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT WERE REQUESTED FROM THE CUSTOMER WITH NO RESPONSE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11314428 ↗
• MalfunctionFeb 4, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE ROLLER AT THE DISTAL END OF THE HF RESECTION ELECTRODE DETACHED AND FELL INTO THE PATIENT. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT, SINCE THE ROLLER WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HF RESECTION ELECTRODE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9664186 ↗
• MalfunctionJan 31, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE ROLLER BALL AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INTO THE PATIENT'S BLADDER. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9652392 ↗
• MalfunctionOct 25, 2019Break; Break

  THE MANUFACTURER WAS INFORMED THAT DURING A THERAPEUTIC PROCEDURE, WHEN DEVICE WAS ACTIVATED THE ROLLER BALL AT THE DISTAL TIP OF THE DEVICE BROKE OFF AND FELL INSIDE THE PATIENT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT WITHOUT HARM. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239373 ↗
• MalfunctionOct 25, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION (TUR) PROCEDURE, THE ROLLER BALL AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE OFF AND FELL INTO THE PATIENT¿S BLADDER. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY USING A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9236951 ↗
• MalfunctionOct 11, 2019Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION (TUR) PROCEDURE, THE ROLLER BALL AT THE DISTAL END OF THE HF-RESECTION ELECTRODE DISLODGED AND FELL INTO THE PATIENT'S BLADDER. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178785 ↗
• MalfunctionAug 1, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE ELECTRODES AXIS THAT WAS HOLDING THE ROLLER BALL BLADE BROKE. IT IS UNKNOWN IF THE ROLLER BALL FELL INTO THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO OTHER EQUIPMENT WAS REPLACED DURING PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8851771 ↗
• MalfunctionAug 1, 2019Break; Break

  THE SERVICE CENTER WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE ELECTRODES AXIS THAT WAS HOLDING THE ROLLER BALL BLADE BROKE. IT IS UNKNOWN IF THE ROLLER BALL FELL INTO THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO OTHER EQUIPMENT WAS REPLACED DURING PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8851343 ↗
• InjuryJul 12, 2018Unclear Information; Unclear Information

  OLYMPUS WAS INFORMED THAT A PATIENT SUSTAINED BURN TO THE PERINEUM DURING A HYSTEROSCOPIC ABLATION PROCEDURE. HOWEVER, IT WAS FURTHER REPORTED THAT THE BURN WAS NOTED AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: Burn(s)

  MAUDE report 7684129 ↗