MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION GENERATOR; ELECTROSURGICAL SYSTEM GENERATOR

Model Number	LP-20-120
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is being returned for service.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the device has a r/f leaking error.No harm reported.Device to be returned for service.No additional information available.Lp-20-120 leep 2025-10-0000526.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Updated: b4, d9, g3, g6, h2, h3, h4, h6, h11.Distribution history: this complaint unit was manufactured at csi on 01/24/2019 and shipped on 02/11/2019.Manufacturing record review: dhr's were reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: there is no service record for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Majority of complaints were not confirmed while others were due to previous issues not relevant on this unit as it had been updated in 2022.Product receipt: the complaint unit was returned 10/17/2025.Visual evaluation: visual examination of the complaint unit revealed physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Any relevant customer or clinical information: ther was no relevant customer or clinical information provided.Root cause: the device tested to specification and found to meet all visual and functional test specifications.A root cause is not applicable as the complaint condition was not confirmed.Note: as the unit was found to be operating to specification it was not confirmed.Coag mode involves higher voltage levels and minimal isolation wear is expected over time.This may result in a slight increase in leakage current.This increase is very small and remains well within the safe limits.No indication rf leakage approached the 120ma limit.Regardless of a small increase of leakage due to wear, the device's electrical leakage monitoring system correctly responded by cutting power.Occurrence is deemed low in probability.The unit was evaluated, adjusted, updated with components r8, r9, r14, and c14 to the most recent revision of the main board, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: LEEP PRECISION GENERATOR
• Common Device Name: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 23475510
• Report Number: 1216677-2025-00051
• Device Sequence Number: 10195784
• Product Code: HGI
• UDI-Device Identifier: 00888937014235
• UDI-Public: (01)00888937014235
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K963653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LP-20-120
• Device Catalogue Number: LP-20-120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown