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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. CAUTERY PENCIL BOX OF 10
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COOPERSURGICAL, INC. CAUTERY PENCIL BOX OF 10 Back to Search Results
Model Number LP-50-101
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Electric Shock (2554)
Event Date 06/28/2017
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. (b)(4).
 
Event Description
(b)(4). "dr. (b)(6) pressed the cut button on the hand piece and got shocked twice. ".
 
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Brand NameCAUTERY PENCIL BOX OF 10
Type of DeviceCAUTERY PENCIL 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
nana banafo
75 corporate drive
trumbull, CT 06611
2036015200
MDR Report Key6692395
MDR Text Key79522224
Report Number1216677-2017-00049
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician Assistant
Remedial Action Replace
Type of Report Initial
Report Date 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2020
Device Model NumberLP-50-101
Device Catalogue NumberLP-50-101
Device Lot Number038408
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/29/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/07/2017 Patient Sequence Number: 1
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