MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE; COUNTER, SPONGE, SURGICAL

Model Number 01-0031

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, the device had a detection three times and then was clear two times.The wound was never re-opened or explored.The circulator said it was detecting in the same exact spot each time.There were no sponge and or laps anywhere close to the area.The staff completed multiple counts to ensure there was no sponge left behind.There was no patient injury.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The returned sample met specification as received.The visual inspection found no visible fe rrite core.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.No corrective action is required, because no reported event was identified, since the product tested satisfactory.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: SITUATE
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• MDR Report Key: 9446376
• MDR Text Key: 191841622
• Report Number: 3005883396-2019-00104
• Device Sequence Number: 1
• Product Code: LWH
• UDI-Device Identifier: 10884521700642
• UDI-Public: 10884521700642
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-0031
• Device Catalogue Number: 01-0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1