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-R090 manufactured by Kaneka Corporation.
[63264135]
-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: there was a hole, from where the bougie was thought to penetrate out, in the sidewall of the tube (colored in clear) where a stainless steel ring was mounted, and 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. - 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
[63264136]
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 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
| Report Number | 9614654-2016-00023 |
| MDR Report Key | 6203742 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-25 |
| Date of Report | 2016-11-11 |
| Date of Event | 2016-11-03 |
| Date Mfgr Received | 2016-11-11 |
| Device Manufacturer Date | 2016-05-25 |
| 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-CITY,, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Manufacturer Phone | 4613072 |
| 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 | 2016-12-25 |
| Returned To Mfg | 2016-11-15 |
| Catalog Number | LF2-R090 |
| Lot Number | KP046378 |
| Device Expiration Date | 2019-04-30 |
| 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 | 2016-12-25 |