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	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is being returned for repair.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the leep would not work in blend mode.Customer believes output of the device to be very low in all three settings.No additional information is available.No patient harm reported.Lp-20-120 (b)(6).
Additional Manufacturer Narrative
Distribution history: this complaint unit was manufactured at csi on 08/07/2024 and shipped on 10/15/2024.Manufacturing record review: dhr's 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 no similar reported complaint condition.Product receipt: the complaint unit was returned on 12/9/2024.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.A root cause is no applicable as the complaint was not confirmed.The unit was evaluated, tested to specifications free of defects.Unit to be processed for a return 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.
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: 20651577
• Report Number: 1216677-2024-00062
• Device Sequence Number: 8284465
• Product Code: HGI
• UDI-Device Identifier: 00888937014235
• UDI-Public: (01)00888937014235
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 10/29/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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