LEEP System 1000® Generator L1000Recalls & reported problems
Coopersurgical, Inc. · LEEP System 1000® Generator · 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 00888937014457), received between May 7, 2023 and May 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2023Mechanical Problem; Mechanical Problem
PEDAL NOT WORKING LEEP SYSTEM 1000 - 110V L1000 E-COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16883701 ↗
Other Electrocautery, Gynecologic (And Accessories) devices
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- ENSEAL X1 NSLX120LEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)2 deaths172 reports
- Fischer Cone Biopsy Excisor 900-157Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)1 recall0 reports
- LEEP PRECISION™ Generator LP-20-120Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)45 reports
- Harmonic NSLX137SEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)1 death19 reports
- LEEP PRECISION™ Integrated System LP-10-120Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)12 reports
- Fischer Cone Biopsy Excisor 900-151Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)10 reports
- AESCULAP PM438RAesculap AG · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.