MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION

Model Number	LP-10-120
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As per the details received on incoming e-complaint (b)(4): "we have a medical incident where both the doctor and patient were shocked during a procedure.".
Additional Manufacturer Narrative
Coopersurgical, inc.Is investigating the reported condition.
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
Distribution history: this complaint unit was manufactured at csi on 06/23/2015.Manufacturing record review: dhr 177428 was reviewed and no non-conformities, related to the complaint condition, were noted.The system dhr was not available.However, each lot is thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.Incoming inspection review: not applicable.Service history record: this unit was serviced for an unconfirmed complaint for low power in 2019.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 a repair.However, based on log (b)(4), this unit was at csi on 6/19/2023.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: the unit functioned free of defects.The unit was returned with a non-cooper name brand electrode without the correct end to connect to the leep precision device.The inclusion of the electrode indicates the customer had used this electrode and determined to be related to the customer's complaint description.Accessory items to be used with the leep precision are noted in the ifu as coopersurgical approved.As such, the complaint condition noted is being attributed to end user error.Note: the unit rf leakage was adjusted to specification but not indicative of a corresponding cause to the complaint.Coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LEEP PRECISION
• Common Device Name: LEEP PRECISION
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16973030
• Report Number: 1216677-2023-00082
• Device Sequence Number: 17823490
• Product Code: HGI
• UDI-Device Identifier: 00888937014228
• UDI-Public: (01)00888937014228
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 05/03/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2015
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown