MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN.

Model Number 52969

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Customer stated "no power to handpieces." repair tech stated "complaint verified.Replaced diaphragm and pad socket." reference repair order #(b)(4).Leep system 1000 esu gen 52969 e-complaint-(b)(4).

Manufacturer Narrative

Investigation.X-inspect returned samples.Analysis and findings.(b)(4).Distribution history: this complaint unit was manufactured at csi on 06/21/2007 under wo #(b)(4) and shipped on 9/14/2007.Manufacturing record review: a review of the device history record could not be performed.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products meet all quality release specifications.Should the device history record be located 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.Product receipt: the complaint unit was returned on repair log 94980.Visual evaluation: visual examination of the complaint unit revealed physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Service & repair confirmed the complaint unit was damaged and required repairs.Root cause: the complaint description of having no power to the handpiece is not accurate or consistent with the update on a working diaphragm.There may be a chance the patient pad was not completing the loop due to the damage and viewed as not having power which is attributable end user handling error not a functional failure of the device.This unit was also noted to have the original diaphragm.Previous issues with the diaphragm requires all units noted to have an original diaphragm will be updated whether they are faulty or not.The issue was due to a latex material degrading over time.A new material, silicone, was selected to replace it as it is not prone to losing its sealing function as did the latex version.Correction and/or corrective action.This unit was repaired, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.Corrective actions relevant to the updated diaphragm are as follows; 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 at this time.Preventative action activity.Coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Customer stated "no power to handpieces" repair tech stated "complaint verified.Replaced diaphragm and pad socket." reference repair order #(b)(4).Leep system 1000 esu gen 52969 (b)(4).

• Brand Name: LEEP SYSTEM 1000 ESU GEN.
• Type of Device: LEEP SYSTEM 1000 ESU 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 drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10694845
• MDR Text Key: 219198265
• Report Number: 1216677-2020-00237
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483DISCO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 52969
• Device Catalogue Number: 52969
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other