MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION

Model Number	LP-10-120
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is investigating the reported conditon.
Event or Problem Description
Additional complaint in ref to (b)(4) second patient incident.Report forwarded by customer service representative trumbull.I got a call from (b)(6) medical center, (b)(4).Their account number is (b)(6).They have the leep precision.The unit is not working correctly and two patients were burned.The serial number is (b)(4).It turns out that is part of the recall.Leep precision intg sys lp-10-120 (b)(4).
Additional Manufacturer Narrative
Distribution history: this complaint unit was manufactured at csi on 01/13/2015 under wo#'s (b)(4) and shipped on 04/27/2015.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 found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Product receipt: the unit was returned.Visual evaluation: complaint unit was identified as a recall unit and processed accordingly.No additional evaluation is required as the issue has already identified this unit as a potentially affected.Functional evaluation: complaint unit was identified as a recall unit and processed accordingly.No additional evaluation is required as the issue has already identified this unit as a potentially affected unit.Root cause: the failure mode on other units was determined to be due to a lack of isolation from the cut signal when operating the coag function.This unit has been identified as a recall unit.Pertaining to the complaint for burnt leg: the unit was repaired and tested with no indication the patient pad testing was suspect.No other information is available but a potential contributing factor may lay in the set up at the time of use or how well the pad was secured to the patient leg.Correction and/or corrective action: the units' board was updated to the latest revision, tested to specifications and returned to the customer.Additional corrections in regard to capa 744 was the release of (b)(4), updating a test procedure, reworking relevant units in wip and recall (b)(4) was initiated.
Event or Problem Description
No additional information.1216677-2022-00160-1 leep precision intg sys lp-10-120 e-complaint- (b)(4).

• 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 VA 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, VA 06611 ; 4752651665
• MDR Report Key: 14515747
• Report Number: 1216677-2022-00160
• Device Sequence Number: 3626025
• Product Code: HGI
• UDI-Device Identifier: 00888937014228
• UDI-Public: (01)00888937014228
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 08/30/2023

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: 05/12/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2015
• 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