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-R105 manufactured by Kaneka Corporation.
[63381458]
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 clear tube was dismounted and missing. Accordingly, the missing stainless steel ring might have been remaining in the patient body. The ring's whereabouts was not confirmed during the procedure in this eye clinic. As a possible cause of the penetration of the bougie and dropping off the ring during, we speculate as follows: when the doctor attempted to pull off the sheath alone forcibly over the tube placed in the lesion, excessive force was loaded on the ring and it resulted in the bougie's penetrating out of the tube with the ring. This report is delayed because it was sent to the emdr test instead of production.
Patient Sequence No: 1, Text Type: N, H10
[63381459]
This device (lacrifast) was employed to treat the epiphora due to lacrimal duct obstruction of (b)(6) female patient. The doctor pre-opened the lacrimal duct by using a dacryoendoscopy and a sheath. Then, he tried to insert one of the pair of lacrimal duct tubes (colored in clear) into the sheath, that was pre-inserted in the lacrimal duct, by using the g-sgi (goto-sheath guided intubation) technique. While advancing the tube with the bougie into the sheath placed in the lacrimal duct, he felt a strong resistance and that the bougie penetrated out of the tube. He retrieved it out of the patient's lacrimal duct, and used another lacrifast to complete the operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2016-00017 |
| MDR Report Key | 6203738 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-25 |
| Date of Report | 2016-07-21 |
| Date of Event | 2016-07-19 |
| Date Mfgr Received | 2016-07-21 |
| Device Manufacturer Date | 2016-03-07 |
| 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 | 2016-07-25 |
| Catalog Number | LF2-R105 |
| Lot Number | KP026310 |
| Device Expiration Date | 2019-01-31 |
| 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 |