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

Model Number	52969
Medical Device Problem Code	Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cooper surgical inc.Is currently investigating the reported condition.Once the investigation is completed a follow-up report will be filed.(b)(4).
Event or Problem Description
Customer stated "recurring er2, even after repositioning pot arrow to 6 o'clock" diaphragm update.Reference repair order: 92184.(b)(4).
Event or Problem Description
Customer stated "recurring er2, even after repositioning pot arrow to 6 o'clock" diaphragm update.Reference repair order: 92184 ref: (b)(4).
Additional Manufacturer Narrative
Ref: (b)(4).Investigation: x-inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals no similar issues.This unit was manufactured april 2010 under wo #85446 and shipped october of 2010.Service and repair confirmed the 'error 2' was due to a faulty micro-board.The main board provides the power but the microprocessor is on the same board as the display and separate from the main board.Once replaced the unit functioned to specifications confirming the issue resides on the micro-board.Further evaluation on the board is not available to pinpoint the specific component.This product is also no longer in production.The last production work order was released into fg in february 3, 2014.A definitive root cause is not available for this complaint condition.Given the age of the device, and no record of a return prior to this one, it is possible this is normal wear and tear.Service & repair also noted this particular failure is not common.This unit was also noted to have the original diaphragm and updated accordingly.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.A seal is needed for the pneumatic switch to turn on the power.Correction and/or corrective action: the micro board was replaced and the diaphragm was updated at a charge.Once the unit was confirmed to pass functional testing it was returned to the customer.This complaint will be entered into the coopersurgical continuous improvement plan (cip).Pertaining to the diaphragm replacement: sustaining 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 applicable correction available to train to.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: LEEP SYSTEM 1000 ESU GEN.
• Common Device Name: LEEP SYSTEM 1000 ESU GEN.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8739538
• Report Number: 1216677-2019-00183
• Device Sequence Number: 2301501
• Product Code: HGI
• Combination Product (Y/N): N
• PMA/510(K) Number: K952483 DISC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 52969
• Device Catalogue Number: 52969
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other