MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS.

Model Number	LP-10-120
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is investigating the reported conditon.
Event or Problem Description
Generator is operating intermittently 1216677-2022-00294 leep precision intg.Sys.Lp-10-120 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples *analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 08/09/2022 under wo's (b)(4) & (b)(4) and shipped on 08/29/2022.Manufacturing record review: dhr's 315272 & 315053 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.Intermittent function was noted on 2 other complaints.One was not returned and the other was related to a recall for lack of isolation in coag mode which is not relevant.Note: this unit was manufactured after the corrective actions were in place under the capa/recall.As such, any similarity in the problem description related to a previous complaint in the 2-year complaint history is coincidental.Product receipt: the complaint unit was processed for a return under rma #(b)(4) and received 11/17/2022.Visual evaluation: visual examination of the complaint unit revealed physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.Root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action the customer was sent a new system.As the returned system was found to function free of defects the generator (lp-20-120) was converted into a demo unit under wo #(b)(4) (b)(6) 2022.The other components of the system were scrapped out.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary no further training required.*was the complaint confirmed? no.
Event or Problem Description
Generator is operating intermittently 1216677-2022-00294-1 leep precision intg sys lp-10-120 e-complaint (b)(4).

• Brand Name: LEEP PRECISION INTG. SYS.
• Common Device Name: LEEP PRECISION INTG. SYS.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15735663
• Report Number: 1216677-2022-00294
• Device Sequence Number: 6316647
• Product Code: HGI
• UDI-Device Identifier: 00888937014228
• UDI-Public: 888937014228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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