MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP BALL ELECTRODE; OPEN-SURGERY ELECTROSURGICAL ELECTRODE, MONOPOLAR, SINGLE-USE

Model Number	B0512
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ball electrodes were not cauterizing.No adverse event reported.No additional information is available.1216677-2024-00001 b0512 ball electrodes 2024-01-0000379.
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Distribution history: the complaint product was manufactured at csi on 07-aug-2023 under work order (b)(4) and was sold on 16-sep-2023.Manufacturing record review: dhr-336585 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt: the complaint product, one box of b0512, was returned in sealed pouches on 25/jan/2024 on rma number (b)(4).The lot number of the returned product matched the lot number reported.Visual evaluation: visual examination of the complaint product revealed no physical damage.Functional evaluation: complaint product was functionally evaluated and found to function properly.5 electrodes were returned in sealed pouches.The 5 electrodes were connected to a leep precision unit and all 5 units transferred electricity when the generator was activated.None of the units that the customer had an issue with were returned.The lot number is depleted from inventory.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.
Event or Problem Description
No additional information is available.

• Brand Name: LEEP BALL ELECTRODE
• Common Device Name: OPEN-SURGERY ELECTROSURGICAL ELECTRODE, MONOPOLAR, SINGLE-USE
• 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: 18631012
• Report Number: 1216677-2024-00001
• Device Sequence Number: 18101495
• Product Code: HGI
• UDI-Device Identifier: 00888937010916
• UDI-Public: (01)00888937010916
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K905747
• 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): 03/06/2024

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 Expiration Date: 07/13/2026
• Device Model Number: B0512
• Device Catalogue Number: B0512
• Device Lot Number: 336585
• 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: 01/26/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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