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 2017-06-26 for LACRIFAST LF2-R90 manufactured by Kaneka Corporation.
[78396113]
- the concerned device "lacrifast" is not distributed in the us under this device name, but is identical to the device "lacriflow lacrimal stent" distributed in the us under 510(k) # k120886. - the actual device used was returned and investigated: no deformation or damage was found in the pair of tubes except for missing the stainless-steel ring mounted in the tip of the tube (colored in clear). - the ring's whereabouts was not confirmed during the procedure in this eye clinic, and accordingly, the missing stainless steel ring might have been remaining in the patient body. - 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 in the tube forcibly in the completely occluded nasal duct, excessive mechanical force was loaded on the ring, where the tip of the bougie touched, and the bougie together with the ring penetrated out of the opening duct in the tip of the tube.
Patient Sequence No: 1, Text Type: N, H10
[78396114]
This device "lacrifast", the lacrimal duct tube, was employed to treat the epiphora due to nasal duct complete occlusion. The doctor tried but failed in opening the occluded nasal duct by inserting a nasal endoscope. Then, he inserted one of the tube (colored in clear) of this device into the nasal duct directly by using the bougie included in this device. While advancing the tube, the doctor felt that the bougie penetrated out of the tube and retrieved it from the patient and found that the stainless-steel ring mounted in the tip of the tube was missing. He used another lacrifast to complete the operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2017-00012 |
| MDR Report Key | 6666130 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-26 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-06-05 |
| Date Mfgr Received | 2017-06-06 |
| Date Added to Maude | 2017-06-26 |
| 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 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Manufacturer Phone | 31814120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LACRIFAST |
| Generic Name | LACRIMAL STENT |
| Product Code | OKS |
| Date Received | 2017-06-26 |
| Catalog Number | LF2-R90 |
| Device Availability | N |
| 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 | 2017-06-26 |