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

Model Number 52969

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation *analysis and findings: a review of the 2 yr complaint history reveals similar issues.This unit was manufactured in 2005.A review of the dhr is not available and not expected to add any more useful information to this investigation.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 is obtained from alsa, an (b)(4) 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 actions: *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 (b)(4), 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.Reason: no applicable training to train to.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.*was the complaint confirmed? yes.

Event Description

Not cauterizing properly.Starts to cauterize then stops - may restart if applying gentle pressure - stops again as if it's extremely sensitive now.Repair log (b)(4).

Event Description

Not cauterizing properly.Starts to cauterize then stops - may restart if applying gentle pressure - stops again as if it's extremely sensitive now.Repair log 85332.Reference e-complaint-(b)(4).

Manufacturer Narrative

Investigation: analysis and findings.A review of the 2 yr complaint history reveals similar issues.This unit was manufactured in 2005.A review of the dhr is not available and not expected to add any more useful information to this investigation.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 is obtained from (b)(4), 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 actions 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, 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.Reason: no applicable training to train to.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
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 75 corporate dr; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 6970239
• MDR Text Key: 90890239
• Report Number: 1216677-2017-00066
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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
• Device Operator: Physician
• Device Model Number: 52969
• Device Catalogue Number: 52969
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other