MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS.; 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	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has indicated that the product is in process of being returned to cooper surgical for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the customer received a new leep machine and it is intermittently turning off during cases.Customer requesting replacement of device.No adverse event reported.No additional information available.Lp-10-120 leep 2023-10-0000142.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 23-feb-2023 under work order (b)(4) and sold on 03-apr-2023.Manufacturing record review: dhr-329343 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no service history record found for this product.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.A review if these similar complaints were reviewed.Most were confirmed and needed the recall update.2 units were not confirmed and 1 unit had rf leakage issue and had the main board changed.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: root cause not applicable as the complaint condition was not confirmed.Corrective actions: 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 is available.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 23-feb-2023 under work order (b)(4) and sold on 03-apr-2023.Manufacturing record review: dhr-329343 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no service history record found for this product.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.A review if these similar complaints were reviewed.Most were confirmed and needed the recall update.2 units were not confirmed and 1 unit had rf leakage issue and had the main board changed.Product receipt: the unit was received from the customer on jan 13, 2024 for service.Visual evaluation: visual examination of the complaint product revealed no physical damage.Functional evaluation: complaint product was functionally evaluated and found to function properly.The service technician could not duplicate the complaint condition.Root cause: root cause not applicable as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.The unit was tested and was found acceptable.
Event or Problem Description
No additional information is available.

• Brand Name: LEEP PRECISION INTG. SYS.
• Common Device Name: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 17931148
• Report Number: 1216677-2023-00135
• Device Sequence Number: 15041018
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2024

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-10-120
• Device Catalogue Number: LP-10-120
• 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): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 01/13/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/19/2023; 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown