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 Information (3190)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The reported condition was not confirmed.The investigation found all the coils passed testing on the tester.The mat was plugged into the console detected sponges.The device did not show that sponges were detected, when the sponges were not present.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the unit had false positive/feedback.

• 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: 8343803
• MDR Text Key: 136280049
• Report Number: 3005883396-2019-00012
• Device Sequence Number: 1
• Product Code: LWH
• UDI-Device Identifier: 10884521700642
• UDI-Public: 10884521700642
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2019

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: 01-0031
• Device Catalogue Number: 01-0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/15/2019
• 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