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	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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).
Additional Manufacturer Narrative
Device is being returned for repair.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Updated: distribution history: this complaint unit was manufactured at csi on 10/29/2024 and shipped on 1/3/2025.Manufacturing record review: dhrs were reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: no additional service history records found 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.Product receipt: the complaint unit was returned 5/06/2025.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Any relevant customer or clinical information: there was no relevant customer or clinical information provided.Root cause: this unit's rf leakage value was determined to be slightly different than what it was set to in the assembly process.Although it was operating within the acceptable watts range and with an amperage value that was well within the limit it was noted to be 5 watts, not 8 when originally set.The change suggests a change in leakage may be due to added current from elsewhere such as the transformer or a capacitor as noted in the dfmea.As the unit was found to be operating to specification it technically 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 customer was sent an entire new generator while the complaint generator was retained for review by engineering as needed.The dfmea was reviewed confirming rf leakage was captured, appropriately rated and lists the monitoring circuit as a control for rf leakage.The pfmea was also confirmed to capture the controls in the assembly process.As the unit operated per its intended design, no additional actions are required.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.
Event or Problem Description
No additional information.

• 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: 22009152
• Report Number: 1216677-2025-00029
• Device Sequence Number: 20131817
• Product Code: HGI
• UDI-Device Identifier: 00888937014235
• UDI-Public: (01)00888937014235
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 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): 07/01/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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