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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. FISCHER CONE BIOP EX SM

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COOPERSURGICAL, INC. FISCHER CONE BIOP EX SM Back to Search Results
Model Number 900-150
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2020
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc. Is currently investigating the reported complaint condition.
 
Event Description
Patient undergoing procedure (biopsy) piece of wire from excisor noted to be missing. Ref e-complaint: (b)(4).
 
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Brand NameFISCHER CONE BIOP EX SM
Type of DeviceFISCHER CONE BIOP EX SM
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull, ct
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate drive
trumbull, ct
Manufacturer Contact
peter niziolek
50 corporate drive
trumbull, ct 
6015200334
MDR Report Key9805984
MDR Text Key191310003
Report Number1216677-2020-00077
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061651
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number900-150
Device Catalogue Number900-150
Device Lot Number26490
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/09/2020 Patient Sequence Number: 1
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