FDA Adverse Event Malfunction Summary report: N

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

MDR report key: 5701678 · Received June 6, 2016

Report

Report Number: 3005883396-2016-00037
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 : 6/6/2016. 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

COVIDIEN REFERENCE #: (B)(4). DATE OF INITIAL REPORT: 06 JUN 2016. DATE OF FOLLOW-UP REPORT: 23 SEP 2016. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. THE INVESTIGATION FOUND THE PRODUCT RETURNED WAS NOT AN RF SURGICAL PRODUCT. WITHOUT THE PRODUCT A DETAILED INVESTIGATION COULD NOT BE PERFORMED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE GAUZE ARE SHREDDING INTO STERILE FIELD AND PATIENT. UNSURE WHICH OF THE FOLLOWING BASIC CUSTOM PACK THIS IS FROM: STERILE KP STD BASIC PACK SHEET, EXP DATE: 2020-10-01, MFT DATE: 2016-04-13 , LOT# 516602 , 508390, 511933, CATALOG KA13BBPKPD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357043	GAUZE, XRAY, RFD, 4X4, 16-PLY, NSTRL, LF, DISP	RF DETECT GAUZE	GDY	RF SURGICAL		151201W

Patients

Seq	Age	Sex	Outcome	Treatment
1