MICROFRANCE? INSTRUMENT 7718

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-11-03 for MICROFRANCE? INSTRUMENT 7718 manufactured by Xomed Microfrance Mfg.

Event Text Entries

[5061290] It was reported that four loop instruments broke after their first use. Follow-up information indicates that each device was used in separate cases. The dates of each case are not known. This regulatory report is being submitted for lot 130902. The remaining loops will be submitted on three separate regulatory reports (medtronic internal reference numbers: (b)(4). The regulatory report numbers were not available at the time of submission. ). There was no injury reported as a result of each event.
Patient Sequence No: 1, Text Type: D, B5


[12547796] No known impact or consequence to patient. (b)(4). Material fragmentation. Four devices were returned for repair/evaluation. The product analysis indicates that the loops were broken right after the laser welds. Two of the four fragments were returned. The other two were recovered and were not in contact with the patient. No material or manufacturing defect was found. The cause of the breaks could not be determined. The breaks may be a result of excessive effort during use. Result: stress problem. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9680837-2014-00094
MDR Report Key4219422
Report Source01,05,06,07
Date Received2014-11-03
Date of Report2014-10-07
Date Mfgr Received2014-10-07
Device Manufacturer Date2013-09-26
Date Added to Maude2014-11-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactURIZA SHUMS
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328405
Manufacturer G1MEDTRONIC XOMED, INC.
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROFRANCE? INSTRUMENT
Generic NameLOOP, WIRE
Product CodeJYQ
Date Received2014-11-03
Returned To Mfg2014-10-13
Model Number7718
Catalog Number7718
Lot Number130902
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerXOMED MICROFRANCE MFG
Manufacturer AddressSAINT-AUBIN-LE-MONIAL BOURBON-L'ARCHAMBAULT 3160 FR 3160


Patients

Patient NumberTreatmentOutcomeDate
10 2014-11-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.