MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-25 for LACRIFAST LF-R105 manufactured by Kaneka Corporation.
[63616098]
- the concerned device "lacrifast" is not distributed in us under this device name, but is identical to the device "lacriflow lacrimal stent" distributed in us under 510(k) # k120886. - 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. The outer/inner diameters, length, and all other dimensions of both tubes were confirmed within the specifications. - the device history record (dhr) of the lacrifast with lot no. Kp025478 was reviewed and no nonconformity or abnormality was found in its manufacturing processes. The device met its material, assembling and product specifications. - 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 heavily occluded lesion, 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 ring with the bougie 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
[63616099]
This device (lacrifast) was employed to treat epiphora due to lacrimal duct occlusion. The doctor inserted one of the lacrimal duct tube (colored in blue) into the occluded lacrimal duct with the bougie provided with this device inserting in the tube. The doctor felt that the bougie penetrated out of the tube and retrieved it out of the patient's lacrimal duct. It was found that the stainless steel ring mounted in the tip of the tube was missing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2015-00011 |
| MDR Report Key | 6203718 |
| Date Received | 2016-12-25 |
| Date of Report | 2015-07-10 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2015-07-10 |
| Device Manufacturer Date | 2015-03-09 |
| Date Added to Maude | 2016-12-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KAZUHIKO INOUE |
| Manufacturer Street | 2-3-18 NAKANOSHIMA, KITA-KU |
| Manufacturer City | OSAKA, OSAKA 5308288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 5308288 |
| Manufacturer Phone | 613072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LACRIFAST |
| Generic Name | LACRIMAL STENT |
| Product Code | OKS |
| Date Received | 2016-12-25 |
| Returned To Mfg | 2015-07-17 |
| Catalog Number | LF-R105 |
| Lot Number | KP025478 |
| Device Expiration Date | 2018-01-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | 2-3-18, NAKANOSHIMA, KITA-KU, OSAKA, 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-25 |