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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-2414-KS1
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/03/2016
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
It was reported that the wire of the cutting loop broke prior to the procedure.There were no injuries or additional procedures reported, and no parts of the device were left in 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 Key8112993
Report Number1820334-2018-03587
Device Sequence Number1487131
Product Code GEI
UDI-Device Identifier00827002462199
UDI-Public(01)00827002462199(17)190317(10)6817249
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
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 Health Professional
Device Expiration Date03/17/2019
Device Catalogue NumberCL-2414-KS1
Device Lot Number6817249
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2016
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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