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

Model Number	E0510
Medical Device Problem Codes	Fire (1245); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a robotic prostate surgery, the cord sparked and caught fire.Pictures were submitted which showed the burnt cord.There was no patient injury.
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 robotic prostate surgery, the cord sparked and caught fire.Pictures were submitted which showed the burnt cord.The fire was put out by the nurse putting the cord in the plastic holder.The procedure was completed using a new opened cord.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received and a visual inspection and functional test were performed.The returned device did not meet specification as received by the supplier."the device was returned without its original packaging, and burn marks/traces were noticeable on its plug.The plug has been burned, and does not meet the definition of the customer drawing." according to the reporter, during a robotic prostate surgery, the cord sparked and caught fire.The reported condition was not confirmed as the device functioned as intended.According to the technician, "after performing the insertion/extraction force test and measuring the resistance of the returned sample, all of the test results are within specifications.The cord functions normally when connected to the generator and another instrument with a 4 mm diameter pin." "the failure mode of the returned sample is similar to the findings of a past event, which indicates that 'arcing' would take place in between the connections if the 4mm pin of the instrument is not fully inserted into the plug, or if the 4mm pin does not make contact with the socket of the plug, resulting in a reported event similar to the complaint defect".Since no manufacturing root cause could be determined, no corrective or preventative action is planned at this time.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: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9847150
• Report Number: 1717344-2020-00309
• Device Sequence Number: 2373144
• Product Code: GEI
• UDI-Device Identifier: 20884524001774
• UDI-Public: 20884524001774
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2020

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: 12/31/2023
• Device Model Number: E0510
• Device Catalogue Number: E0510
• Device Lot Number: 1811210X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 05/28/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 05/28/2020; 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1