LEEP PRECISION™ Generator LP-20-120Recalls & reported problems
Coopersurgical, Inc. · LEEP PRECISION™ Generator (120 VAC) · Class 2
All models of LEEP PRECISION Generator (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Coopersurgical LEEP Precision generator is a surgical electrosurgical unit used for LEEP procedures in gynecology. The 45 adverse event reports mostly describe electrical problems — units with no power or no output to the wand, and one that would not cut, with a burned smell when the case was opened. One injury and no deaths were reported. There are no recalls for this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00888937014235), received between May 7, 2022 and Jul 30, 2026 — classified as 1 injury, 44 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (40 reports).
9 other recalls cover devices cleared under the same FDA submission (K963653); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem40
- Mechanical Problem9
- Insufficient Device Problem Information1
- Output Problem1
- Therapeutic or Diagnostic Output Failure1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50083838 ↗MalfunctionApr 21, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE LEEP UNIT WOULD NOT CUT OR BLEND. THERE WAS A BURNED SMELL WHEN CASE COVER REMOVED. UNIT TO BE RETURNED FOR REPAIR. NO ADDITIONAL INFORMATION AVAILABLE. 1216677-2026-00033 LP-20-120 LEEP (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944913 ↗MalfunctionJan 23, 2026Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24160380 ↗MalfunctionJan 6, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THERE IS NO POWER GOING TO WAND. THE UNIT GETS NO OUTPUT. NO PATIENT HARM REPORTED. DEVICE BEING RETURNED FOR REPAIR. NO ADDITIONAL INFORMATION. LP-20-120 LEEP 2025-12-0000327.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974845 ↗MalfunctionDec 16, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817790 ↗MalfunctionNov 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23635857 ↗MalfunctionNov 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23475510 ↗MalfunctionNov 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23475407 ↗MalfunctionJul 1, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22373510 ↗MalfunctionMay 13, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025, THE LEEP DEVICE GAVE AN R/F ERROR WHEN ATTEMPTING TO COAG. THEY WERE ABLE TO BLEND AND CUT FINE BUT GOT AN ERROR WHEN ATTEMPTING TO COAG. NO PATIENT HARM. NO ADDITIONAL INFORMATION AVAILABLE. DEVICE TO BE RETURNED FOR REPAIR. LP-20-120 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009152 ↗MalfunctionMay 12, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002160 ↗MalfunctionMay 12, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LEEP UNIT SHUT OFF MID-PROCEDURE. THE DOCTOR FINISHED THE PROCEDURE WITH MANUAL REMOVAL OF TISSUE. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. DEVICE TO BE RETURNED FOR REPAIR. LP-20-120 LEEP (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002159 ↗MalfunctionApr 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937679 ↗MalfunctionApr 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21935238 ↗MalfunctionApr 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21930184 ↗MalfunctionApr 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752377 ↗InjuryMar 14, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
MalfunctionMar 12, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE LEEP DEVICE WAS LOSING ELECTRICAL CURRENT TO HAND PIECE WHILE CUTTING, RESULTING IN CHANGING HAND PIECES MULTIPLE TIMES. PROCEDURE WAS ABLE TO BE COMPLETED. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION. 1216677-2025-00011 LP-20-120 LEEP (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21583331 ↗MalfunctionJan 31, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21283187 ↗MalfunctionJan 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21178094 ↗MalfunctionNov 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20796764 ↗MalfunctionNov 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE LEEP WOULD NOT WORK IN BLEND MODE. CUSTOMER BELIEVES OUTPUT OF THE DEVICE TO BE VERY LOW IN ALL THREE SETTINGS. NO ADDITIONAL INFORMATION IS AVAILABLE. NO PATIENT HARM REPORTED. LP-20-120 (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651577 ↗MalfunctionOct 18, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT WHILE PERFORMING AN UNKNOWN OBGYN PROCEDURE, THE LEEP WOULD NOT CUT. NO PATIENT HARM REPORTED. UNIT TO RETURN FOR REPAIR. NO ADDITIONAL INFORMATION. LP-20-120 LEEP 2024-10-0000210.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20480491 ↗MalfunctionAug 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937901 ↗MalfunctionJul 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE UNIT IS NOT CUTTING. DEVICE TO BE RETURNED FOR REPAIR. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. LP-20-120 LEEP (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19741039 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K963653. One submission often covers many models, so check the product and lot details in each record.
- Z-0263-2022 · Sep 29, 2021 · Open, ClassifiedQuantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
- Z-0260-2022 · Sep 29, 2021 · Open, ClassifiedLEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
- Z-0262-2022 · Sep 29, 2021 · Open, ClassifiedQuantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
- Z-0259-2022 · Sep 29, 2021 · Open, ClassifiedLEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
- Z-0261-2022 · Sep 29, 2021 · Open, ClassifiedQuantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
- Z-0600-2020 · Oct 16, 2019 · TerminatedQuantam 2000 Electrosurgical Generator, Part number 909075.
- Z-0602-2020 · Oct 16, 2019 · TerminatedQuantam 2000 Electrosurgical Generator, Part number 909075-05W.
- Z-0601-2020 · Oct 16, 2019 · TerminatedQuantam 2000 Electrosurgical Generator, Part number 909075-05.
- Z-2057-2019 · Jun 18, 2019 · TerminatedLEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
Other Electrocautery, Gynecologic (And Accessories) devices
- Enseal NSLX137CEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)3 deaths344 reports
- 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
- 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
- Valleylab E1564Covidien LP · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)6 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page