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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. HANDPIECE BOX OF 10
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COOPERSURGICAL, INC. HANDPIECE BOX OF 10 Back to Search Results
Model Number 6040
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).
 
Event Description
We have attempted several procedures and leep did not work with this hand piece.The loops were not cutting, several loops were tried and the cutting was sluggish the procedure was completed with the use of scalpel.
 
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Brand Name
HANDPIECE BOX OF 10
Type of Device
HANDPIECE BOX OF 10
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer Contact
peter niziolek
75 corporate drive
trumbull, CT 06611
MDR Report Key8445950
MDR Text Key139807832
Report Number1216677-2019-00134
Device Sequence Number1
Product Code HAM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K884174
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/22/2019
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 No Information
Device Expiration Date07/28/2017
Device Model Number6040
Device Catalogue Number6040
Device Lot Number024234
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/07/2019
Initial Date FDA Received03/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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