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U.S. Department of Health and Human Services

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

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COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN Back to Search Results
Model Number 52969
Device Problem Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 09/16/2021
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
 
Event Description
This device was sent in for pm and evaluation of diaphragm.Order: (b)(4).Verified--replaced diaphgram and front case mod.Re-adjust output power.Leep system 1000 esu gen 52969 e-complaint-(b)(4).
 
Event Description
This device was sent in for pm and evaluation of diaphragm.Order: (b)(4).-verified--replaced diaphgram and front case mod.Re-adjust output power.1216677-2021-00228 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 09/18/2003 under wo #(b)(4) and shipped on 11/06/2003.Manufacturing record review: a review of the device history record could not be performed as the 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 to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint 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 one similar reported complaint condition.Product receipt: the complaint unit was returned on a repair log 97040.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 complaint is considered confirmed due to the unit being sent for pm.This unit was noted to have the original diaphragm and updated accordingly.Previous issues with the diaphragm requires all units noted to have an original diaphragm will be updated whether they are faulty or not.The issue was due to a latex material degrading over time.A new material, silicone, was selected to replace it as it is not prone to losing its sealing function as did the latex version.A seal is needed for the pneumatic switch to turn on the power.*correction and/or corrective action sustaining 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, 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.*preventative action activity : coopersurgical will continue to monitor this complaint condition for trends.
 
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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 Key12616467
MDR Text Key278086447
Report Number1216677-2021-00228
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 Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number52969
Device Catalogue Number52969
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/27/2021
Initial Date FDA Received10/12/2021
Supplement Dates Manufacturer Received09/27/2021
Supplement Dates FDA Received11/10/2022
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 Number1
Patient Outcome(s) Other;
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