MAUDE Adverse Event Report: RF SURGICAL CONSOLE, RF ASSURE MODEL 200LD-V; SPONGE DETECTION SYSTEM

Catalog Number 01-0034

Device Problems False Reading From Device Non-Compliance (1228); Device Contamination with Chemical or Other Material (2944)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The return of the unit has been requested.To date it has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that during a vaginal delivery a scan with a verisphere and console detected cotton x2.A new console was brought in and detection was clear, no cotton.No x-ray used.

Manufacturer Narrative

(b)(4).Date of follow-up report : 7/15/2016.The device was returned and the investigation did not identify anything that would have caused or contributed to the reported event.The device was found to function normally and within specification.A review of the device history records indicated that this serial number was released meeting all specifications as manufactured.The concomitant device has not been received for evaluation.

• Brand Name: CONSOLE, RF ASSURE MODEL 200LD-V
• Type of Device: SPONGE DETECTION SYSTEM
• Manufacturer (Section D): RF SURGICAL; 5927 landau court; carlsbad CA 92008
• Manufacturer (Section G): RF SURGICAL; 5927 landau court; carlsbad CA 92008
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5663255
• MDR Text Key: 46624364
• Report Number: 3005883396-2016-00028
• Device Sequence Number: 1
• Product Code: LWH
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01-0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• 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: Reuse
• Patient Sequence Number: 1