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

Model Number 52969

Device Problems Failure to Cut (2587); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Information (3190)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: x-inspect returned samples.Analysis and findings: the complaint unit was manufactured on march 2008 and shipped to the customer on april 17, 2008.A review of the 2 year complaint history for the leep system 1000 esu gen.Shows similar complaint conditions on file.Service & repair confirmed the complaint and had replaced the diaphragm to repair the device.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.This particular failure is actually not due to the foot pedal portion of the device, but another component inside the housing.Air displacement pushes on a piston, via a 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 degraded condition the sealing properties are impacted and it will not function as intended.The root cause for this complaint condition is being attributed to degradation of the diaphragm.Correction and/or corrective action: coopersurgical service and repair team replaced the diaphragm on the unit and returned it 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.The repaired unit will have been repaired with this new silicone material.This is not an assembly issue.Complaints will continue to be monitored to determine if there is any new trend for this complaint condition.Was the complaint confirmed? yes.

Event Description

Review of service and repair logs: customer stated "will not cauterize or cut".(b)(4).

• Brand Name: LEEP SYSTEM 1000 ESU GEN.
• Type of Device: LEEP SYSTEM 1000 ESU GEN.
• Manufacturer (Section D): COOPERSURGICAL, INC.; corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 50 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 8692303
• MDR Text Key: 150892415
• Report Number: 1216677-2018-00045
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/12/2019

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
• Device Operator: Health Professional
• 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: 07/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2008
• 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