MAUDE Adverse Event Report: RF SURGICAL SYSTEMS INC. RF ASSURE DETECTION SYSTEM; SPONGE DETECTION SYSTEM

Lot Number NP

Device Problems Unable to Obtain Readings (1516); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

A conclusive root cause for the reported event could not be determined because the console and sponge used in the surgical case were not returned for evaluation.There was no apparent detection system fault, as the system function was verified during the surgical case, as stated in the report.The technique used to scan the lap sponge could not be determined.The rf assure detection system is indicated for use as an adjunct system to hospital safety protocols including manual sponge counting.

Event Description

Sponge missed during scan during a c-section.Surgical staff performed manual count and discovered console sn (b)(4) missed one lap sponge during mat scan.Unaccounted lap sponge was found visually.Console was able to scan the lap after the 7th time.Lap was scrapped.Product functioned properly when tested post-procedure.

• Brand Name: RF ASSURE DETECTION SYSTEM
• Type of Device: SPONGE DETECTION SYSTEM
• Manufacturer (Section D): RF SURGICAL SYSTEMS INC. ; 5927 landau ct.; carlsbad CA 92008
• Manufacturer Contact: tom kane, director qa/ra ; 5927 landau ct; carlsbad, CA 92008 ; 7608271473
• MDR Report Key: 5382806
• MDR Text Key: 36706538
• Report Number: 3005883396-2016-00001
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: NP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other