MAUDE Adverse Event Report: COOK INC COOK CUTTING LOOP; GEI UNIT, ELECTROSURGICAL AND ACCESSORIES

Catalog Number	CL-2414-KS1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2015
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 the following information: after using a cook cutting loop on a patient they needed to use a roller ball.The cutting loop was removed and the roller ball could not be installed.A roller ball from another manufacturer also could not be installed.At that moment it was noted that the proximal end of the stem had severed from the stem itself and remained lodged in the resectoscope, preventing the installation of any electrode.This product problem did not result in any reported serious injuries.

• 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 Key: 8108879
• Report Number: 1820334-2018-03358
• Device Sequence Number: 16577399
• Product Code: GEI
• UDI-Device Identifier: 00827002462199
• UDI-Public: (01)00827002462199(17)180303(10)5689912
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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 Date: 03/03/2018
• Device Catalogue Number: CL-2414-KS1
• Device Lot Number: 5689912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/27/2018
• Patient Sequence Number: 1