MAUDE Adverse Event Report: COOPERSURGICAL, INC. REFURB LEEP PRECISION GEN

Model Number	DMLP-20-120
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
As per details reported on (b)(4) from fs log # 100398."intermittent rf leakage during use.".
Additional Manufacturer Narrative
Distribution history: this complaint unit was manufactured at csi on 5/20/2016 under wo#'s (b)(4) and converted to demo on work order (b)(4) on 8/4/2016.Manufacturing record review: dhrs 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 found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.However, based on log 100398, this unit was at csi on (b)(6) 2023.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: although not confirmed on this unit capa 801 had been issued to determine a root cause on rf leakage complaints.Based on the findings, the design is intact and not faulty.The leep system is designed with a safety feature to cut power in any mode when rf leakage is detected.This is in place to protect the end user and patient from potential shock.In the investigation, the failure had been repeated, but under certain conditions relevant to set up/environment.The unit was evaluated, tested and returned to the customer.All product was placed on hold and later released per an evaluation of the findings on the capa investigation.The investigation portion of the capa process will be considered complete but the implementation portion will continue with some actions based on the investigation.Coopersurgical will continue to monitor this complaint condition for trends.
Event or Problem Description
No additional information is available.

• Brand Name: REFURB LEEP PRECISION GEN
• Common Device Name: REFURB LEEP PRECISION GEN
• 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 dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 17050265
• Report Number: 1216677-2023-00089
• Device Sequence Number: 17909308
• Product Code: HGI
• UDI-Device Identifier: 00888937019926
• UDI-Public: (01)00888937019926
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: DMLP-20-120
• Device Catalogue Number: DMLP-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): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/15/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2016
• 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: Other
• Patient Sex: Unknown