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

Model Number 52969

Device Problem Loss of Power (1475)

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

Event Date 11/15/2015

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint was returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

Review of repair order (b)(4).Per repair authorization form: "when foot pedal was pressed it functioned a bit then stopped.No power for cutting or cautery.Changed handpiece, loop return pad, pen - still 0 power." (b)(4).

Manufacturer Narrative

Investigation: initiated manufacturer's investigation.No sample returned.Review dhr.X-inspect returned samples.Inspect stock product.Analysis and findings: a review of the 2 yr complaint history reveals similar issues.This unit was manufactured in 2010.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 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.Correction and/or corrective action: the issue is being investigated by sustaining engineering to address the issue with corrective actions.Currently, an alternate material, silicone, is being investigated that is less prone to degradation.Additionally, a technical bulletin is now available providing leep customers with guidance on detecting the issue.This is not an assembly issue.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.

Event Description

Review of repair order log 80634.Per repair authorization form: "when foot pedal was pressed it functioned a bit then stopped.No power for cutting or cautery.Changed handpiece, loop return pad, pen - still 0 power." (b)(4).

Manufacturer Narrative

This concludes coopersurgical' s root cause investigation.Coopersurgical, inc.Will continue to monitor the complaint condition for tending and safety.

Event Description

(b)(4).Per repair authorization form: "when foot pedal was pressed it functioned a bit then stopped.No power for cutting or cautery.Changed handpiece, loop return pad, pen - still 0 power." (b)(4).

• Brand Name: LEEP SYSTEM 1000 ESU GEN.
• Type of Device: LEEP SYSTEM 1000 ESU GEN.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 coporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5614222
• MDR Text Key: 44724201
• Report Number: 1216677-2016-00003
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/28/2016; 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2010
• 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