Elite Iglesias EIWE-PKFLRecalls & reported problems
Gyrus ACMI, LLC · Elite Iglesias Bipolar Front-Loading Working Element For Gyrus ACMI PK SuperPulse System · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925011229), received between Jan 28, 2024 and Jan 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fire” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2024Fire; Fire
THE CUSTOMER REPORTED TO OLYMPUS, THE PK FRONT LOAD, (B)(6), WORKING ELEMENT CAUGHT FIRE DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18592929 ↗
Other CYSTOURETHROSCOPE devices
- n.a. 11272C1Karl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall16 reports
- n.a. 11272VNUKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall4 reports
- n.a. 27050CAKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE54 reports
- C-VIEW 11272VKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
- n.a. 11272VNKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
- C-VIEW 11272VAKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
- C-VIEW 11272VUAKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 reports
- C-VIEW 11272VUKarl Storz GmbH & Co. KG · CYSTOURETHROSCOPE1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page