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

Model Number	LP-10-120
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device location 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 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.
Additional Manufacturer Narrative
Updated: b4, d9, g3, g6, h2, h3, h4, h6, h7, h11.Distribution history: this complaint unit was manufactured at csi on 11/23/2023.Manufacturing record review: dhr's 341330 & 330586 were reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: this unit was reviewed and required an adjustment to r77 in april of 2025.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Majority of complaints were not confirmed.The remaining complaints are similar to this one.Product receipt: the complaint unit was initially returned for the generator only on 6/9/2025 and updated to have the rest of the entire system returned.The cart, integration unit and smoke evacuator (system) was not yet received.Visual evaluation: visual examination of the generator revealed no physical damage.Functional evaluation: the generator was functionally evaluated and found to function properly.However, service & repair confirmed the unit rf leakage test for coag was now different from last service from 6 to 11 watts.Root cause: the leakage threshold was last set (in coag mode) to 6 watts via an adjustment to r77.The generator was found to be at 11 watts, but still within the allowable range per procedure.However, since the value had changed in an unexpected direction additional engineering review was required and included the request for the rest of the system to be sent in.Although not technically confirmed, the issue is deemed as confirmed due to such an odd observation in the setting.The customer was provided with an entirely new system.This unit was set aside to have the rest of the system returned to have it further evaluated as a system which includes the integration unit, smoke evacuator and the cart.An update to the complaint can be attached should relevant information by engineering be provided.
Event or Problem Description
No additional information.

• Brand Name: LEEP PRECISION INTEGRATED SYSTEM
• 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: 22212308
• Report Number: 1216677-2025-00034
• Device Sequence Number: 18307706
• Product Code: HGI
• UDI-Device Identifier: 00888937014228
• UDI-Public: (01)00888937014228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K963348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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-10-120
• Device Catalogue Number: LP-10-120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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