I12C4f Transducer 9066Recalls & reported problems
Bk Medical Aps · Intraoperative · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05704916000219), received between Jul 18, 2023 and Aug 2, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Handling Problem” (2 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 18, 2026.
Most reported problems
Device problems
- Device Handling Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2023Device Handling Problem; Device Handling Problem
MOR REPORT MW5113739. RECEIVED BY BK MEDICAL 16-DEC-2022. EVENT DESCRIPTION: WHEN INSERTING THE BK MEDICAL LAPAROSCOPIC PROBE THE SHEATH COVERING THE FLEXIBLE TIP TORE AND A PIECE FELL IN PATIENT ABDOMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17443876 ↗InjuryJul 18, 2023Device Handling Problem; Device Handling Problem
MDR REPORT MW5113739. RECEIVED BY BK MEDICAL 16-DEC-2022. EVENT DESCRIPTION: WHEN INSERTING THE BK MEDICAL LAPAROSCOPIC PROBE THE SHEATH COVERING THE FLEXIBLE TIP TORE AND A PIECE FELL IN PATIENT ABDOMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17341765 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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