NA 0504880314Recalls & reported problems
Stryker Corporation · [Cutting Loop Electrode, .014 wire, 24 Fr ¿ 90 ¿, Only for use with Stryker Resectoscopes 0502-880-401, 0502-880-402, Do not use if package is damaged] · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327055436), received between Oct 23, 2018 and Dec 9, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient3
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2021Break
IT WAS REPORTED THAT THE DEVICE BROKE AND THE BROKEN PIECE FELL INSIDE THE PATIENT. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 12970648 ↗MalfunctionDec 12, 2019Fracture
IT WAS REPORTED THAT THE ELECTRODE WAS FRACTURED DURING THE PROCEDURE. THE FRACTURE DID NOT TAKE PLACE INSIDE THE PATIENT AND NO PIECES FELL INTO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9461875 ↗MalfunctionOct 23, 2018Break
IT WAS REPORTED THAT THE TIP OF THE ELECTRODE BROKE OFF INSIDE THE PATIENT. ALL BROKEN PIECES WERE RETRIEVED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7997093 ↗MalfunctionOct 23, 2018Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE ELECTRODE BROKE OFF INSIDE THE PATIENT. ALL BROKEN PIECES WERE RETRIEVED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7997091 ↗
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- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall353 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall1 death332 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid2 recalls75 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5ROlympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid114 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5ROlympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall54 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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