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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC COOK CUTTING LOOP; GEI UNIT, ELECTROSURGICAL AND ACCESSORIES
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COOK INC COOK CUTTING LOOP; GEI UNIT, ELECTROSURGICAL AND ACCESSORIES Back to Search Results
Catalog Number CL-2412-12-OL
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
The complainant reported that the cook cutting loop was broken when the package was opened.This product problem was noted prior to use, and there was no reported impact to the patient.
 
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Brand Name
COOK CUTTING LOOP
Common Device Name
GEI UNIT, ELECTROSURGICAL AND ACCESSORIES
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key8110283
Report Number1820334-2018-03464
Device Sequence Number202516
Product Code GEI
UDI-Device Identifier00827002462281
UDI-Public(01)00827002462281(17)181013(10)6280533
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/28/2018
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
Operator of Device No Information
Device Expiration Date10/13/2018
Device Catalogue NumberCL-2412-12-OL
Device Lot Number6280533
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2018
Initial Report FDA Received Date11/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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