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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 Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/29/2021
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported conditon.
 
Event Description
E-complaint: (b)(4).Report forwarded by service & repair- unit would not coagulate and patient had to go via ambulance to emergency room.Another leep unit was used successfully to stop bleeding.Leep precision generator lp-20-120.E-complaint- (b)(4).
 
Event Description
(b)(4).Report forwarded by service & repair- unit would not coagulate and patient had to go via ambulance to emergency room.Another leep unit was used successfully to stop bleeding.1216677-2021-00070 leep precision generator lp-20-120 (b)(4).
 
Manufacturer Narrative
Investigation x-review dhr x-inspect returned samples.*analysis and findings (b)(4).Distribution history: this complaint unit was manufactured at csi on 10/17/2019 under wo (b)(4) and shipped on (b)(6) 2019.Manufacturing record review: dhr's (b)(4) were reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: this unit was returned for unconfirmed intermittent function noted on log 95722 february 16, 2021.The unit was fitted with a new board as a precaution.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on (b)(4).Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.*correction and/or corrective action the customer was provided with a new generator.The returned unit was found to function to specifications free of defects.As the inspection of this unit did not provide a confirmation of the described complaint, or any defects, this unit was sent to engineering to be further evaluated.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.*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 Key11665468
MDR Text Key260990534
Report Number1216677-2021-00070
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
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 10/31/2022
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 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
Initial Date Manufacturer Received 03/29/2021
Initial Date FDA Received04/14/2021
Supplement Dates Manufacturer Received03/29/2021
Supplement Dates FDA Received10/31/2022
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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