LACRIFAST LF2-R105

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-12-25 for LACRIFAST LF2-R105 manufactured by Kaneka Corporation.

Event Text Entries

[63264965] The concerned device "lacrifast" is not distributed in us under this device name, but is the actual device used was returned and investigated:the stainless steel ring mounted in the tip of the colored in blue tube was dismounted and missing. Accordingly, the missing stainless steel ring might have been remaining in the patient body. The ring's whereabouts was not confirmed during the procedure in this eye clinic. As a possible cause of the penetration of the bougie and dropping off the ring during the use, we speculate as follows: when the doctor tried to insert and advance the tube with the bougie inserted forcibly in the occluded lacrimal duct, excessive mechanical force was loaded on the ring and the distal tip of the tube where the ring was mounted, and further pushing the bougie resulted in dismounting the ring and penetration of the bougie with the ring out of the tube. This report is delayed because it was sent to the emdr test instead of production.
Patient Sequence No: 1, Text Type: N, H10


[63264966] This device (lacrifast) was employed to treat the epiphora due to lacrimal duct obstruction. The doctor inserted one of the lacrimal duct tube (colored in blue) into the lacrimal duct. While advancing the tube, the doctor felt that the bougie penetrated out of the tube and retrieved it out of the patient's lacrimal duct. He used another lacrifast and completed the operation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614654-2016-00018
MDR Report Key6203739
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2016-12-25
Date of Report2016-08-02
Date of Event2016-07-29
Date Mfgr Received2016-08-02
Device Manufacturer Date2016-01-25
Date Added to Maude2016-12-25
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 FDA3
Event Location3
Manufacturer ContactMR. KAZUHIKO INOUE
Manufacturer Street2-3-18 NAKANOSHIMA,KITA-KU
Manufacturer CityOSAKA-CITY, OSAKA 530-8288
Manufacturer CountryJA
Manufacturer Postal530-8288
Manufacturer Phone4613072
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLACRIFAST
Generic NameLACRIMAL STENT
Product CodeOKS
Date Received2016-12-25
Returned To Mfg2016-08-04
Catalog NumberLF2-R105
Lot NumberKP125346
Device Expiration Date2016-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerKANEKA CORPORATION
Manufacturer Address2-3-18 NAKANOSHIMA, KITA-KU OSAKA, OSAKA 530-8288 JA 530-8288


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-12-25

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