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

Model Number	01-0043R
Medical Device Problem Codes	False Positive Result (1227); Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2018
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, prior to use, the unit would shutdown often and when it scan, it got wrong readings.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one device sample was received for evaluation.From the provided information, it is unknown if the device has or has not been used in the treatment or diagnosis of a patient.The returned sample did not meet specification as received.The visual inspection found no notable conditions.The investigation isolated the failure to a software issue.The software was reloaded to address the condition.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SITUATE
• Common Device Name: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• MDR Report Key: 7664872
• Report Number: 3005883396-2018-00059
• Device Sequence Number: 2527486
• Product Code: LWH
• UDI-Device Identifier: 10884521705319
• UDI-Public: 10884521705319
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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 Model Number: 01-0043R
• Device Catalogue Number: 01-0043R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 07/16/2018; 08/08/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/06/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1