ProMax™ Series Bard® C-Max™ Cutting Loop 355315Recalls & reported problems
C. R. Bard, Inc. · ProMax™ Series Bard® C-Max™ Cutting Loop, Resectoscope Compatibility: Storz Single Stem 27 Fr. · Class 2
- 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 00801741018589), received between Apr 19, 2017 and Apr 19, 2017 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2017Break
IT WAS REPORTED THAT A PIECE OF THE CUTTING LOOP BROKE OFF INSIDE THE PATIENT. THE PIECE WAS ALLEGEDLY ABLE TO BE RETRIEVED DURING THE INITIAL SURGERY AND NO PATIENT INJURY WAS REPORTED. DURING A HYSTEROSCOPY RESECTOSCOPE PROCEDURE, ONE END OF THE LOOP DETACHED FROM THE STEM OF THE SHAFT. HOWEVER, THERE WERE NO BROKEN PIECES. THE LOOP WAS RETRIEVED DURING THE SURGERY AND ALL OF THE LOOP WAS ACCOUNTED FOR. A DIFFERENT LOOP WAS OBTAINED AND THE PROCEDURE WAS COMPLETED.
Patient problems: Foreign Body In Patient
MAUDE report 6505162 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.