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

Model Number	LP-10-120
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is functioning properly per customer and is not being returned.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an unknown procedure on (b)(6) 2025, that the leep was shutting off when using the coagulation button.Upon consultation with csi employee, it was determined that the leep machine was not connected to a wall outlet during the procedure and the connection to the machine was loose.Customer was able to figure out what the problem was, and the machine is now working properly.No patient harm reported.No additional information provided.1216677-2025-00014 lp-10-120 leep 2025-03-0000333.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h4, h6, h11.Distribution history: this complaint unit was manufactured at csi on 10/18/2021 and shipped on 10/26/2021.Manufacturing record review: dhr's 310577 & 296641 were reviewed and no non-conformities, related to the complaint condition, were noted.None of the observed notes indicate a similar issue.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history does not reveal similar reported complaint conditions.Product receipt: the unit was not returned.Visual evaluation: a visual evaluation could not be completed as the complaint unit was not required to be returned to coopersurgical.Functional evaluation: a functional evaluation could not be completed as the complaint unit was not required to be returned to coopersurgical.Root cause: the information on the complaint and a discussion with service & repair indicates the customer had not used a wall outlet and likely had not had the generator fully seated in cart.The power to the generator comes from connecting to the internal connector in the cart slot.Also, the unit must be powered from a wall outlet per the ifu.This is attributable to end user error.
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: 21752114
• Report Number: 1216677-2025-00014
• Device Sequence Number: 12820987
• Product Code: HGI
• UDI-Device Identifier: 00888937014228
• UDI-Public: (01)00888937014228
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown