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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 - 110V LEEP 1000

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COOPERSURGICAL, INC. LEEP SYSTEM 1000 - 110V LEEP 1000 Back to Search Results
Model Number L1000
Device Problem Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2017
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. Ref: (b)(4). ***update*** *investigation: inspect returned samples. *analysis and findings: a review of the 2 yr complaint history reveals similar issues. A review of the dhr is not available and not expected to add any more useful information to this investigation. This unit was manufactured in 2009. 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 (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. *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, (b)(4). The dfu was also updated to add a safety check via (b)(4). 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. This complaint will be entered into the coopersurgical continuous improvement plan (cip). Reason: this is not an assembly issue. Complaints will be continuously monitored to determine if there is any new trend for this complaint condition. *was the complaint confirmed? yes - (b)(4).
 
Event Description
Reference (b)(4). "when pedal is pressed machine functions for 3 seconds and then shuts down. If you wait 10 sec and then it will work for another 3 seconds. " s&r log # (b)(4).
 
Manufacturer Narrative
Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. (b)(4).
 
Event Description
(b)(4). "when pedal is pressed machine functions for 3 seconds and then shuts down. If you wait 10 sec and then it will work for another 3 seconds. " (b)(4).
 
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Brand NameLEEP SYSTEM 1000 - 110V
Type of DeviceLEEP 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 Key6581166
MDR Text Key195171902
Report Number1216677-2017-00034
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberL1000
Device Catalogue NumberL1000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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