Sharpoint 62-2450GRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2.4 mm CC3D+ Slit, Angled, Advanced Double Bevel · Class 1
- 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 00848782044399), received between Sep 24, 2024 and Sep 24, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
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.
MalfunctionSep 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED ON AUGUST 30, 2024 THAT THE KNIFE DID NOT PERFORM AS EXPECTED DURING THE INCISION LEADING TO THE WOUND NOT SEALING PROPERLY AND SUTURES WERE ADDED AFTER THE INCISION. NO ADDITIONAL INJURIES REPORTED; HOWEVER, THE FAILURE RESULTED IN A SIGNIFICANT PROCEDURAL DELAY AS SURGICAL INTERVENTION WAS REQUIRED.
Patient problems: Laceration(s)
MAUDE report 20292443 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.