FDA Adverse Event Malfunction Summary report: N

GAUZE, XRAY, RFD, 4X4, 16-PLY, NSTRL, LF, DISP

MDR report key: 5701647 · Received June 6, 2016

Report

Report Number: 3005883396-2016-00035
Event Type: Malfunction
Date Received: June 6, 2016
Date of Event: May 13, 2016
Report Date: May 16, 2016
Manufacturer: RF SURGICAL
Product Code: GDY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DATE OF INITIAL REPORT: 06/06/2016. TO DATE THE DEVICE 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. A REVIEW OF THE MANUFACTURING NON CONFORMANCES WAS COMPLETED AND INDICATES ALL PARAMETERS AND ACCEPTANCE CRITERIA FOR ENTRIES POTENTIALLY PERTINENT TO THE CUSTOMER REPORT WERE WITHIN SPECIFIED LIMITS AT THE TIME OF RELEASE.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION CONFIRMED THE REPORTED INCIDENT. THE INVESTIGATION FOUND THAT THE GAUZE WAS UNFOLDED AND UNRAVELING. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE MISUSE OF THE PRODUCT. AS MENTIONED IN THE DFR; UNFOLDING GAUZE SPONGES CAN EXPOSE WOVEN EDGES AND RADIOPAQUE MARKER TO DAMAGE. THE DFU ALSO STATES, GAUZE SPONGES ARE MADE WITH NATURAL COTTON AND MAY PRODUCE LINT OR FIBERS WHEN UNFOLDED OR MANIPULATED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE GAUZE INSIDE THE STD BASIC PACK HAD LOOSE FRAGMENT AND 5CM THREAD FOUND IN THE WOUND, GENERAL CASE. NO PATIENT INTERVENTION NEEDED. STERILE KP STD BASIC PACK, EXP DATE: 2020-10-01, MFT DATE: 2016-04-13, LOT# 516602, CATALOG: KA13BBPKPD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
356878	GAUZE, XRAY, RFD, 4X4, 16-PLY, NSTRL, LF, DISP	RF DETECT GAUZE	GDY	RF SURGICAL		151001W

Patients

Seq	Age	Sex	Outcome	Treatment
1