Busse Hospital Disposables 284Recalls & reported problems
Robert Busse & CO., Inc. · 12mm Curved Vacuum Curette · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849233009820), received between Dec 22, 2023 and Dec 22, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged Prior to Receipt by User1
- Device Damaged Prior to Use1
- Material Fragmentation1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2023Material Fragmentation; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023, (B)(6) HOSPITAL DISPOSABLES RECEIVED AN EMAIL REPORT FROM (B)(6). THE REPORT INDICATED THAT A PRODUCT, SPECIFICALLY LOT#1920275 FOR CATALOG 284 (BUSSE'S 12MM CURETTE), HAD BROKEN DURING SURGERY ON (B)(6) 2023. AFTER OBTAINING ADDITIONAL INFORMATION FROM (B)(6) ABOUT THE INCIDENT, ON (B)(6) 2023, BUSSE HOSPITAL DISPOSABLES FORMALLY SUBMITTED A 3500A. THIS SUBMISSION IS INTENDED TO PROVIDE AN UPDATE TO OUR ORIGINAL REPORT, INCORPORATING OBSERVATIONS FROM OUR INVESTIGATION AND INSPECTIONS CONDUCTED, AND TO CONCLUDE THE REPORT.
Patient problems: Laceration(s)
MAUDE report 18384278 ↗
Other Curette, Uterine devices
- Sklar Instruments 96-4113Sklar Corporation · CURETTE, UTERINE1 recall0 reports
- AESCULAP ER223RAesculap AG · CURETTE, UTERINE2 reports
- AESCULAP ER402RAesculap AG · CURETTE, UTERINE2 reports
- V. Mueller GL1625Steris Corporation · CURETTE, UTERINE1 report
- V. Mueller GL1600-003Steris Corporation · CURETTE, UTERINE1 report
- CARDINAL HEALTH SMA11LSJH3Cardinal Health 200, LLC · CURETTE, UTERINE1 report
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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