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 2017-10-29 for LACRIFAST LF2-R105 manufactured by Kaneka Corporation.
[91103251]
- 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). - 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 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
[91103252]
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 clear) into the obstructed lacrimal duct. While advancing the tube, the doctor felt strong resistance and gave up to further insert the tube, and he retrieved it out of the patient's lacrimal duct. When the actual device used was investigated, the ring was dismounted and missing. 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. He used another lacrifast and completed the operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009761573-2017-00004 |
| MDR Report Key | 6986216 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-10-29 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-10-17 |
| Device Manufacturer Date | 2017-05-08 |
| Date Added to Maude | 2017-10-29 |
| 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 | 2017-10-29 |
| Returned To Mfg | 2017-09-27 |
| Catalog Number | LF2-R105 |
| Lot Number | KP047292 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-10-29 |