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

Model Number	SURGII-8
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Inaccurate Delivery (2339); Noise, Audible (3273)
Health Effect - Clinical Code	No Information (3190)
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, the unit had a loose folie hanging out and a speaker with creaking noise.Return electrode monitoring(rem) test failed by increased resistance to 20 ohm.There was no patient involvement.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Evaluation summary: one device was received as a service request and a visual inspection and functional test were performed.The returned device did not meet specification as received by the supplier.Return electrode monitoring (rem) test failed by increased resistance to 20 ohm.The reported condition was confirmed.According to the technician, "issue confirmed.Unit needs all updates u4 heatsink update, speaker update, analog nem to digital nem update, encoders, main pcb barrier, display configuration prom, s/n and model labels.Unit needs all updates per wi-tsu-006_3." the investigation identified the cause of the reported event to be wear and tear.The following upgrades were performed: two encoder spacers, main pcb barrier, speaker with one 100 ohm resistor and one inch shrink tubing; u4 heatsink with one nut and screw; nem with one digital nem pcb, nem configuration prom, nem mounting bracket, two nylon screws, two nylon nuts; two 2.7 ohm resistors, one screw, one nut, and one lockwasher; display configuration prom rev c, s/n and model labels.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: SURGISTAT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9072442
• Report Number: 1717344-2019-01178
• Device Sequence Number: 13898674
• Product Code: GEI
• UDI-Device Identifier: 10884521035928
• UDI-Public: 10884521035928
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K001955
• 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,Followup
• Report Date (Section B): 12/08/2019

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 Model Number: SURGII-8
• Device Catalogue Number: SURGII-8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/21/2019; 11/22/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 11/05/2019; 12/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1