MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS. 120VAC; 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	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the leep device would not cut with the hand switch.Unit to be returned for repair.No additional information is available.Lp-10-120 leep (b)(4).
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
No additional information.
Additional Manufacturer Narrative
Updated: b4, d4, d9, g3, g6, h2, h3, h4, h6, h7, h11.Distribution history: this complaint unit was manufactured at csi on 10/10/2019 under and shipped on 12/10/2019.Manufacturing record review: dhr's (b)(4) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt: the product was returned 8/13/2024 via rma # (b)(4).Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.The unit did not operate in the cut and blend modes using the hand piece.The coag mode did work.When using the foot pedal all modes were functional.Any relevant customer or clinical information: ther was no relevant customer or clinical information provided.Root cause: failure of electrical component.The board was replaced with a new one from stock, tested to specifications and returned to the customer.This was determined to be an isolated incident.Coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LEEP PRECISION INTG. SYS. 120VAC
• 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: 20036673
• Report Number: 1216677-2024-00045
• Device Sequence Number: 11531850
• Product Code: HGI
• UDI-Device Identifier: 00888937014228
• UDI-Public: (01)00888937014228
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 2019080068
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/23/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown