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.
[63620969]
- 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 rings mounted in the tip of both tubes were dismounted and missing. The outer/inner diameters, length, and all other dimensions of both tubes were confirmed within the 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 inserted bougie forcibly in the insufficiently opened lacrimal duct by the pre-probing procedure, 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 penetration of the bougie with the ring out of the tube.
Patient Sequence No: 1, Text Type: N, H10
[63620970]
This device (lacrifast) was employed to treat the epiphora due to lacrimal duct obstruction of a (b)(6) male patient. The doctor opened the lacrimal duct by using a metal bougie, then inserted one of a pair of the lacrimal duct tubes into the lacrimal duct by dsi (direct silicone intubation) technique. 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 tried to place the other one of the pair of the lacrimal duct tubes, but the same problem occurred. He used another lacrifast and completed the operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2015-00016 |
| MDR Report Key | 6203722 |
| Date Received | 2016-12-25 |
| Date of Report | 2015-11-17 |
| Date of Event | 2015-09-26 |
| Date Mfgr Received | 2015-11-17 |
| Device Manufacturer Date | 2015-01-28 |
| 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 | 2-3-18NAKANOSHIMA, KITA-KU |
| Manufacturer City | OSAKA, OSAKA 5308288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 5308288 |
| Manufacturer Phone | 4613072 |
| Manufacturer G1 | KANEKA CORPORATION |
| Manufacturer Street | 2-3-18 NAKANOSHIMA, KITA-KU, |
| Manufacturer City | OSAKA, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 530-8288 |
| 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 | 2015-11-17 |
| Catalog Number | LF-R105 |
| Lot Number | KP015034 |
| Device Expiration Date | 2017-12-31 |
| 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, OSAKA 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-25 |