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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).
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Type of DeviceLEEP SYSTEM 1000 ESU GEN
Manufacturer (Section D)
75 corporate dr
trumbull CT 06611
Manufacturer (Section G)
75 corporate dr
trumbull CT 06611
Manufacturer Contact
nana banafo
75 corporate dr
trumbull, CT 06611
MDR Report Key6970239
MDR Text Key90890239
Report Number1216677-2017-00066
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 10/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number52969
Device Catalogue Number52969
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2005
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/23/2017 Patient Sequence Number: 1