Cervical Biopsy Punch 1Recalls & reported problems
Dtr Medical Limited · Cervical Rotating Biopsy Punch · Class 1
Data updated Oct 18, 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 05060411985339), received between Sep 10, 2026 and Sep 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Mechanical Jam1
Patient problems
- Pain1
- Pelvic Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break; Mechanical Jam
During a cervical biopsy procedure, the upper portion of the biopsy punch handle fractured during use, resulting in the cutting tip becoming lodged in the patient's cervix. The device was removed by carefully rotating/manipulating the device, which caused additional patient pain. No device components remained in the patient. No bleeding beyond that normally expected for the procedure was reported.
Patient problems: Pain; Pelvic Pain
MAUDE report 50710337 ↗
Other Forceps, Biopsy, Gynecological devices
- Trinity Sterile, Inc. 96-4137MTrinity Sterile, Inc. · FORCEPS, BIOPSY, GYNECOLOGICAL1 recall0 reports
- AESCULAP ER063RAesculap AG · FORCEPS, BIOPSY, GYNECOLOGICAL2 reports
- Kevorkian-Pacific biopsy punch 64-675Coopersurgical, Inc. · Forceps, Biopsy, Gynecological1 report
- Integra® Miltex® 30-1495Integra Lifesciences Production Corporation · FORCEPS, BIOPSY, GYNECOLOGICAL1 report
- AESCULAP ER064RAesculap AG · FORCEPS, BIOPSY, GYNECOLOGICAL1 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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