Classic Series C650-129ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925008700), received between May 28, 2021 and Oct 26, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 reports).

1 FDA recall record name this device's identifier.

6 other recalls cover devices cleared under the same FDA submission (K890328); they may or may not involve this specific model.

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. Apr 17, 2018Terminated

   There is a potential for the cord to spark and cause a fire.

   Z-1952-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Disconnection; Sparking; Disconnection; Sparking

  THE CUSTOMER REPORTED THERE WAS A SPARK WHILE USING THE SUBJECT DEVICE AND IT BROKE FROM THE CONNECTION POINT. THE CUSTOMER WAS ADVISED THAT THE DEVICE WAS PART OF A RECALL AND SHOULD NOT HAVE BEEN IN USE. ADDITIONAL DETAILS WERE REQUESTED REGARDING THE REPORTED EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673615 ↗
• MalfunctionSep 22, 2022Disconnection; Sparking; Disconnection; Sparking

  OLYMPUS RECEIVED A MEDWATCH REPORT VIA EMAIL ON AUGUST 26, 2022 . THE MEDWATCH REPORT STATED DURING A SURGICAL PROCEDURE - CYSTOSCOPY WITH FULGURATION, A SPARK OCCURRED AT THE JUNCTION OF THE BUGBEE ELECTRICAL CORD AND THE BUGBEE ELECTRODE. THE MALE ADAPTER ON THE BUGBEE CORD BECAME COMPLETELY DISCONNECT DURING THE SPARK. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468766 ↗
• MalfunctionSep 9, 2021Fire; Fire

  AS REPORTED, DURING A BLADDER BIOPSY AND FULGURATION DIAGNOSTIC PROCEDURE, THE ACMI MONOPOLAR CORDS (C650-129A) USED WITH A BUGBEE ELECTRODE (ACMI 257F8) CAUGHT FIRE DURING USE. THE INCIDENT OCCURRED AFTER BRIEF INTERMITTENT USE OF INSTRUMENTS FOR SEVERAL MINUTES. THE CORD WAS REPLACED WITH A DIFFERENT CORD OF THE SAME KIND. THE INTENDED PROCEDURE WAS COMPLETED WITH NO HARM OR INJURY TO THE PATIENT . NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450747 ↗
• MalfunctionMay 28, 2021Break; Material Separation; Break; Material Separation

  IT IS REPORTED AFTER AN UNSPECIFIED PROCEDURE USING A MONOPOLAR ACTIVE CORD WITH A BUGBEE ELECTRODE, WHEN THE ELECTRODE WAS DISCONNECTED FROM THE ACTIVE CORD, THE ELECTRODE WAS IN SO TIGHTLY THAT THE ACTIVE CORD BROKE. THE UNIT WORKED NORMALLY FOR THE ENTIRE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. WHEN THE DOCTOR ATTEMPTED TO DISCONNECT THE ELECTRODE FROM THE ACTIVE CORD, IT WAS INCREDIBLY DIFFICULT. WHEN THE PHYSICIAN PULLED THE ELECTRODE OUT, THE ACTIVE CORD WAS DAMAGED. THE BLUE PROTECTIVE COATING BROKE OFF THE CORD, AND AT THIS THE AREA OF THE CORD, THE PHYSICIAN EXPERIENCED AN ELECTRICAL SHOCK. THE PHYSICIAN REQUIRED NO TREATMENT FOR THE SHOCK EXPERIENCED.

  Patient problems: Electric Shock

  MAUDE report 11901470 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K890328. One submission often covers many models, so check the product and lot details in each record.

• Z-3299-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
• Z-3300-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
• Z-2720-2026 · May 5, 2026 · Open, Classified
  Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
• Z-2139-2025 · Jun 18, 2025 · Open, Classified
  Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some
• Z-2140-2025 · Jun 18, 2025 · Open, Classified
  Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the work
• Z-0568-2024 · Oct 2, 2023 · Open, Classified
  ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF M