MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EDGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E1450-6
Medical Device Problem Codes	Material Fragmentation (1261); Peeled/Delaminated (1454); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the surgeon was unable to cut skin with pencil.When switched the long tip, it was noticed that some of the coating flaked off into the patient's cavity, but fully retrieved.There was no patient injury.After the procedure, the same generator used on another case and it worked fine.
Additional Manufacturer Narrative
Adevaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found that the insulation was damaged and became loose.The reported damage to the insulation was confirmed.The investigation found that the insulation was damaged and scraped off, consistent with the damage that occurs when the electrode had been grasped by a metal object or had come into contact with a sharp object.Electrodes are 100% inspected prior to shipment and those with mechanical damage to the insulation are rejected.The investigation identified the root cause of the reported event to be attributed to user handling damage.The instructions for use (ifu) states that before use, examine the electrosurgical unit and accessories for defects.Do not use cables or accessories with damaged (cracked, burned, or taped) insulation or connectors.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8418245
• Report Number: 1717344-2019-00329
• Device Sequence Number: 16512535
• Product Code: GEI
• UDI-Device Identifier: 10884521713130
• UDI-Public: 10884521713130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K955836
• 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,Followup
• Report Date (Section B): 04/08/2019

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: 07/29/2023
• Device Model Number: E1450-6
• Device Catalogue Number: E1450-6
• Device Lot Number: 82070359X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1