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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 Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2020
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical, inc. Is currently investigating the reported condition.
 
Event Description
Customer stated "will not cut". Repair tech stated "complaint verified". Reference repair order #: (b)(4). System 1000 esu gen 52969 (b)(4).
 
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Brand NameLEEP SYSTEM 1000 ESU GEN.
Type of DeviceLEEP 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
peter niziolek
50 corporate drive
trumbull, CT 06611
2036015200
MDR Report Key10634839
MDR Text Key249926537
Report Number1216677-2020-00220
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952483DISCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number52969
Device Catalogue Number52969
Device Lot NumberN/A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
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 Treatment Data
Date Received: 10/06/2020 Patient Sequence Number: 1
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