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

Model Number 52969

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.The device involved in the complaint was returned to the customer and evaluated.Once the investigation is completed a follow-up will be filed.Reference complaint: (b)(4).

Event Description

Review of service and repair log # (b)(4).Follow up questionnaire: "foot pedal failed to work during the procedure.Patient was taken to the or for suture placement." reference complaint: (b)(4).

Manufacturer Narrative

(b)(4).A review of the dhr is not available but not expected to provide useful information for this complaint.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.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 dfu was also updated to add a safety check.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.This complaint will be entered into the coopersurgical continuous improvement plan (cip).

Event Description

Review of service and repair log # (b)(4).Follow up questionnaire: "foot pedal failed to work during the procedure.Patient was taken to the o.R.For suture placement." (b)(4).

• Brand Name: LEEP SYSTEM 1000 ESU GEN.
• Type of Device: LEEP 1000
• 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 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6064628
• MDR Text Key: 59020049
• Report Number: 1216677-2016-00078
• 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: consumer,health professional
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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: 10/17/2016
• Is the Reporter a Health Professional?: No
• Device Age: 8 YR
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2005
• 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): Required Intervention