MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE; ERYTHROCYTE SUSPENSION, MULTI SPECIES, SEROLOGICAL REAGENT AND EQUIPMENT

Model Number 01-0031

Device Problem False Positive Result (1227)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The investigation found all the coils passed testing on the tester.The mat was plugged into the console detected sponges.Engineering reviewed the console log information.Since the nurse¿s report and extra equipment in groin area aligns with the log investigation, it is pretty likely that the pump was the reason the customer saw a false positive ¿ it interfered with the mat at approximately the same frequency that the mat scans for a tag and gave a ¿detect¿ to error on the side of patient safety.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, post open heart procedure, a sponge was detected with both the wand and body scanner at the end of the procedure and the counts were shown to be correct.X-ray was done to rule out the presence of a sponge and it was determined that nothing was left in the patient.There was a maquet balloon pump and temporary pacer in the groin of the patient, which was placed in the catheterization laboratory prior to the surgery.The wand was sensing something in the groin area of the patient where these devices were located.When one console was falsely detected a tagged piece of cotton they attempted to verify that no cotton was present with the second console.

• Brand Name: SITUATE
• Type of Device: ERYTHROCYTE SUSPENSION, MULTI SPECIES, SEROLOGICAL REAGENT AND EQUIPMENT
• 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: 8500499
• MDR Text Key: 141496402
• Report Number: 3005883396-2019-00020
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/10/2019
• 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
• Patient Outcome(s): Required Intervention