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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION GENERATOR

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COOPERSURGICAL, INC. LEEP PRECISION GENERATOR Back to Search Results
Model Number LP-20-120
Device Problems Mechanical Problem (1384); Failure to Cut (2587)
Patient Problem Insufficient Information (4580)
Event Date 03/25/2021
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported conditon.
 
Event Description
Cut/coug, interm during use.Order: (b)(4).Complaint verified.Rpelaced pcb.(b)(4).
 
Event Description
Cut/coug, interm during use.Order: (b)(4).
 
Manufacturer Narrative
Investigation x-review dhr.X-inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 02/09/2016 under wo (b)(4) & (b)(4) and shipped on 3/21/2016.Manufacturing record review: dhr's (b)(4) & (b)(4) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the attached 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log (b)(4).Visual evaluation: visual examination of the complaint unit revealed no outer physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Complaint was not duplicated.Root cause : no definitive root cause for this issue could be reliably determined at this time.The rf leakage found by service & repair is a functional failure not associated with the problem description and therefore not considered confirmation of intermittent function.The unit was noted to have a loose bj3, but the issue was not duplicated.Correction and/or corrective action the unit was fitted with a new board, bj3 was tightened, the unit was tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.
 
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Brand Name
LEEP PRECISION GENERATOR
Type of Device
LEEP PRECISION GENERATOR
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 Key11671194
MDR Text Key247915588
Report Number1216677-2021-00076
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 10/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLP-20-120
Device Catalogue NumberLP-20-120
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2021
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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