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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. 100 VOLT LEEP 1000 GENERA
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COOPERSURGICAL, INC. 100 VOLT LEEP 1000 GENERA Back to Search Results
Model Number L1000J
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2019
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.Ref (b)(4).
 
Event Description
Customer stated "stepping on the footswitch can apply an electricity only for a while.It becomes unable to do it after a while.After leaving the device for a while, even though it can resume the energization, the device repeats the error over and over.Please make a thorough inspection and repair the device".Reference repair order #: (b)(4).Ref: (b)(4).
 
Event Description
Customer stated "stepping on the footswitch can apply an electricity only for a while.It becomes unable to do it after a while.After leaving the device for a while, even though it can resume the energization, the device repeats the error over and over.Please make a thorough inspection and repair the device" reference repair order # (b)(4).Ref: (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 10/01/10 under wo #86285 and shipped on 2/16/11.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at this time.However, at the time of manufacture, records from each unit are reviewed to ensure that product meet all specifications.Should the device history record be located, this complaint will be amended accordingly.Incoming inspection review: n/a.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 conditions.Product receipt: the complaint unit was returned on a repair.However, based on log 93354, this unit was at csi on 11/20/2019.Visual evaluation: visual examination of the complaint unit revealed physical damage.Three micro mounts were broken off.Functional evaluation: unit was not functioning properly.Root cause: the diaphragm is 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 and loses its seal and cannot function properly.The diaphragm is 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.The root cause for this complaint condition is component related to the diaphragm.The other findings are being attributed to end user handling and likely some wear as the coag output required an adjustment.*correction and/or corrective action coopersurgical service and repair replaced the diaphragm on the unit, tested it and returned it to the customer.Engineering has successfully tested a replacement material made of silicone for use in repairs going forward, eng-test-10341-r.The ifu 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.*preventative action activity reference eng-test-10341-r and ecn-20444.
 
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Brand Name
100 VOLT LEEP 1000 GENERA
Type of Device
100 VOLT LEEP 1000 GENERA
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull, ct CT 06611
MDR Report Key9676702
MDR Text Key191403258
Report Number1216677-2020-00029
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
PMA/PMN Number
K952483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Repair
Type of Report Initial,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberL1000J
Device Catalogue NumberL1000J
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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