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	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while performing an unknown obgyn procedure, the leep would not cut.No patient harm reported.Unit to return for repair.No additional information.Lp-20-120 leep 2024-10-0000210.
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
Distribution history: this complaint unit was manufactured at csi on 10/10/2019 and shipped on 12/10/2019.Manufacturing record review: dhrs 269843 & 269835 were reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: this unit was serviced august 13, 2024 for a faulty main board.The main board was replaced, tested, and returned to the customer.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.As this unit was not confirmed to have a functional issue there is no relevancy.Product receipt: the product was returned 10/10/2024.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 device tested to specification and found to meet all visual & functional test specifications.A root cause is not applicable as the complaint condition was not confirmed.The unit was tested to specification free of defects 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: 20480491
• Report Number: 1216677-2024-00059
• Device Sequence Number: 8275794
• Product Code: HGI
• UDI-Device Identifier: 00888937014235
• UDI-Public: (01)00888937014235
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2019
• 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