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

Model Number 52969

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.(b)(4).

Event Description

Per customer's statement on repair authorization form " not heating up, stopped in a procedure".Reference repair order: (b)(4).

Event Description

Per customer's statement on repair authorization form " not heating up, stopped in a procedure".Reference repair order: (b)(4).Ref e-complaint-(b)(4).

Manufacturer Narrative

Ref e-complaint-(b)(4).Investigation: x- inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals similar issues.This unit was manufactured in 2010 under wo #(b)(4).A review of the dhr is not available and not expected to add any more useful information to this investigation.Service & repair did not confirm the complaint condition.The returned items included the 2 connectors and the foot pedal.No disposable items were available from the customer.The unit was checked with the returned items and found to function to specifications.There is no root cause for this complaint condition.It is likely the end user error has contributed to the complaint condition through improper use of the device.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; none.An in-service was requested for this customer.The unit was updated with a new diaphragm and tested to specifications before returning to the customer.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.Corrective actions related to the diaphragm: sustaining engineering has successfully tested a replacement material made of silicone for use in assembly and repairs going forward, eng-test-10341-r.The ifu was also updated to add a safety check via ecn-20444, p/n 35387b.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.Correction activity in 2016.No applicable correction available to train to at this time.Was the complaint confirmed? yes.

• 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
• MDR Report Key: 8565683
• MDR Text Key: 143801011
• Report Number: 1216677-2019-00063
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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 This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other