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

Model Number 52969

Device Problem Device Stops Intermittently (1599)

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

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).

Event Description

Service and repair log 88381 review: when pressing on pedal to cauterize it would work for about 6 seconds then would stop working.Changed the 1- adapter plug, 2- adapter for patient, 3- leep ball electrode, 4- foot controlled handle with standard blade electrosurgical handle.Would reposition the adapter plug - foot controlled handle and it would work approximately another 4-6 seconds then stop again.

Event Description

Service and reapir log 88381 review: when pressing on pedal to cauterize it would work for about 6 seconds then would stop working.Changed the 1- adapter plug, 2- adapter for patient, 3- leep ball electrode, 4- foot controlled handle with standard blade electrosurgical handle.Would reposition the adapter plug - foot controlled handle and it would work approximately another 4-6 seconds then stop again.

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.Reference (b)(4).Update 5/16/2018.Investigation: inspect returned samples: analysis and findings; a review of the 2 yr complaint history reveals no similar issues.This unit was manufactured in 2010.Service and repair confirmed the foot pedal was not properly functioning.The foot pedal is used to activate the device.If not functioning the power to the unit will not flow and it will not cut.The unit was obtained from alsa, an italian manufacturer, and integrated with csi products with minor adjustments that does not involve modifications to the internal board.The foot pedal has been known to fail due to a few reasons.The most common is the diaphragm which acts as the mechanism to make contact (for electrical current) to supply power to the unit.Air displacement pushes on a piston via the diaphragm into a switch to turn the power on.The foot pedal creates the air displacement to the pneumatic switch mechanism located in the housing of the unit.The diaphragm breaks down just enough to lose its seal and cannot function properly.The diaphragm material has been described as a rubber, possibly a latex.Given the appearance of a bad diaphragm it appears to have been exposed to excessive stimuli.Materials like latex are 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 and it will not function as intended.The root cause for this complaint condition is component related to the diaphragm.Corrective action: correction and/or corrective action; the unit was repaired and returned to the customer.Sustaining engineering has successfully tested a replacement material made of silicone for use in assembly and repairs going forward, eng-test-10341-r.The dfu 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.Corrective action level 3.None reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.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.; 75 corporate dr; trumbull CT 06611
• MDR Report Key: 7379492
• MDR Text Key: 103937085
• Report Number: 1216677-2018-00013
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 52969
• Device Catalogue Number: 52969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention