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

Model Number 52969

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Foot p.Not working.Order: (b)(4).Replaced diagram.(b)(4).

Event Description

Foot p.Not working.Order: (b)(4).Replaced diagram.1216677-2021-00165: leep system 1000 esu gen 52969 e-complaint: (b)(4).

Manufacturer Narrative

Investigation: x-inspect returned samples.Analysis and findings: complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 10/16/2009 under wo #(b)(4) and shipped on (b)(6) 2009.Manufacturing record review: a review of the device history record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed.Should the device history record be located going forward this complaint will be amended accordingly.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on repair log 96682.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: the foot pedal is used to activate the device.If not functioning the power to the unit will not flow.The foot pedal has been known to fail due to a few reasons.The most common is the diaphragm in the switch 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 in the switch to turn the power on.The foot pedal creates the air displacement to the pneumatic switch.Given the appearance of a bad diaphragm it appears to have been exposed to excessive stimuli.Latex is 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.The root cause for this complaint condition is component related to the diaphragm.Correction and/or corrective action.Preventative action activity: 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.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.

• 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
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 12333228
• MDR Text Key: 268451868
• Report Number: 1216677-2021-00165
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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 the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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