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

Model Number 01-0043R

Device Problems False Positive Result (1227); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

One device was received for evaluation.The returned sample did not meet specification as received by medtronic.The visual inspection found broken front case assy.The console's faceplate pried off was confirmed, but could not duplicated issues with mats.The investigation found the most probable cause of the reported event to be the broken front case assy.The front case assy was replaced to address the condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during unit inspection, the console's faceplate pried off and had issues with mats.Tried another mats but only with particular mat that has issue with this console.It was giving an extended scan using the mat that would end in a detection message even there was no sponge around.However, they knew their manual count was correct.They then moved to the wand and that did not detect anything.Replaced with new console and it worked fine.There was no patient involvement.

• Brand Name: SITUATE
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• Manufacturer (Section G): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 8526944
• MDR Text Key: 142373728
• Report Number: 3005883396-2019-00025
• Device Sequence Number: 1
• Product Code: LWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2019

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
• Device Operator: 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: 04/03/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1