MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 - 110V

Model Number	L1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currenlty investigating the reported condition.
Event or Problem Description
The details of (b)(4) as reported on fs log # 100254 : "pedal not working - can override by pusly site on machine with small wooden cotton tip applicator." leep system 1000 - 110v l1000 (b)(4).
Additional Manufacturer Narrative
Investigation inspect returned samples analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured in 1997.Manufacturing record review: a review of the device history record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed.Should the device history record be located going forward this complaint will be amended accordingly.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.Similar complaints on file were addressed with corrective actions in 2016 to prevent re-occurrence.See corrective action section for details.Product receipt: the complaint unit was returned on a repair.However, based on log (b)(4) this unit was at csi on 04/25/2023.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.Root cause: the foot pedal has been known to fail due to a few reasons.The most common is the diaphragm in the switch (within the console) which acts as the mechanism to make an electrical contact to supply power to the unit.Air displacement, generated by the foot pedal, pushes on a piston via the diaphragm in the switch to turn the power on.Given the appearance of a bad diaphragm it appears to have been exposed to excessive stimuli.Latex is flexible hence the use in this application, but its elastic properties can alter over time as well.In this condition, the sealing properties are impacted.The root cause for this complaint condition is component related to the diaphragm.Correction and/or corrective action coopersurgical service and repair replaced the diaphragm on the unit, tested it and returned it to the customer.Engineering has successfully tested a replacement material made of silicone for use in repairs going forward, eng-test-10341-r.The ifu was also updated to add a safety check via ecn-20444.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.All product in fg and sk, as applicable, were reworked to replace the previous versions of the dfus on all applicable products.The repaired unit will have been repaired with this new silicone material.No further training required.Was the complaint confirmed? yes.
Event or Problem Description
Pedal not working leep system 1000 - 110v l1000 e-complaint (b)(4).

• Brand Name: LEEP SYSTEM 1000 - 110V
• Common Device Name: LEEP SYSTEM 1000 - 110V
• 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: 16883701
• Report Number: 1216677-2023-00074
• Device Sequence Number: 5830304
• Product Code: HGI
• UDI-Device Identifier: 00888937014457
• UDI-Public: 888937014457
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K952483
• 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: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: L1000
• Device Catalogue Number: L1000
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/07/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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