LEEP PRECISION™ Integrated System LP-10-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888937014228), received between May 26, 2022 and Aug 20, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (9 reports).

4 other recalls cover devices cleared under the same FDA submission (K963348); 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Electrical /Electronic Property Problem

  It was reported that the device gave an R/F Leakage error and didn't cauterize as it should. Unit to be returned for repair. No patient harm. (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50348310 ↗
• MalfunctionSep 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097162 ↗
• MalfunctionJun 16, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHILE ATTEMPTING TO ENTER COAG MODE, THE DEVICE GIVES A "R/F LEAKAGE ERROR." DEVICE TO BE RETURNED FOR SERVICE. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. LP-10-120 LEEP 2025-06-0000090.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212308 ↗
• MalfunctionApr 2, 2025Loss of Power; Loss of Power

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752114 ↗
• MalfunctionAug 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036673 ↗
• MalfunctionAug 21, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED VIA MEDWATCH, THAT THE PATIENT WAS SCHEDULED TO UNDERGO A LEEP (LOOP ELECTROSURGICAL EXCISION PROCEDURE) ON (B)(6) 2024. THE LEEP UNIT WAS FOUND TO NOT FUNCTION PROPERLY WHEN TURNED ON. THERE WAS A PROBLEM WITH THE FOOT PEDAL CONTROL. BEFORE THE PROCEDURE WAS TO BEGIN, THE PATIENT REPORTED FEELING PAIN AND THE PROVIDER STATED THAT THE UNIT WAS ALREADY HOT. PATIENT DECLINED PROCEDURE DUE TO THE FEELING OF PAIN. PROVIDER INFORMED NURSE THAT THE DEVICE DID ARC TO THE PATIENT WITHOUT USING FOOT PEDAL. PATIENT WAS GIVEN IBUPROFEN FOR PAIN TREATMENT. PATIENT VITALS WERE STABLE AND SHE WAS DISCHARGED. ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE, BUT NO RESPONSE PROVIDED. LP-10-120 LEEP (B)(4).

  Patient problems: Pain

  MAUDE report 20016062 ↗
• MalfunctionOct 24, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999294 ↗
• MalfunctionOct 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931148 ↗
• MalfunctionSep 25, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808681 ↗
• MalfunctionMay 22, 2023Output Problem; Output Problem

  AS PER THE DETAILS RECEIVED ON INCOMING E-COMPLAINT (B)(4): "WE HAVE A MEDICAL INCIDENT WHERE BOTH THE DOCTOR AND PATIENT WERE SHOCKED DURING A PROCEDURE.".

  Patient problems: Electric Shock

  MAUDE report 16973030 ↗
• MalfunctionNov 4, 2022Output Problem; Output Problem

  GENERATOR IS OPERATING INTERMITTENTLY 1216677-2022-00294 LEEP PRECISION INTG. SYS. LP-10-120 E-COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735663 ↗
• MalfunctionMay 26, 2022Electrical /Electronic Property Problem; Nonstandard Device; Output Problem; Electrical /Electronic Property Problem

  ADDITIONAL COMPLAINT IN REF TO (B)(4) SECOND PATIENT INCIDENT. REPORT FORWARDED BY CUSTOMER SERVICE REPRESENTATIVE TRUMBULL. I GOT A CALL FROM (B)(6) MEDICAL CENTER, (B)(4). THEIR ACCOUNT NUMBER IS (B)(6). THEY HAVE THE LEEP PRECISION. THE UNIT IS NOT WORKING CORRECTLY AND TWO PATIENTS WERE BURNED. THE SERIAL NUMBER IS (B)(4). IT TURNS OUT THAT IS PART OF THE RECALL. LEEP PRECISION INTG SYS LP-10-120 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn

  MAUDE report 14515747 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963348. One submission often covers many models, so check the product and lot details in each record.

• Z-0258-2022 · Sep 29, 2021 · Open, Classified
  LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
• Z-0257-2022 · Sep 29, 2021 · Open, Classified
  LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
• Z-2057-2019 · Jun 18, 2019 · Terminated
  LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
• Z-1840-2019 · Apr 23, 2019 · Terminated
  LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Ge