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 2017-04-24 for LACRIFAST LF2-R105 manufactured by Kaneka Corporation.
[73457210]
-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 not returned. 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. - the device history record (dhr) of the lacrifast with lot no. Kp126196 was reviewed and no nonconformity or abnormality was found in its manufacturing processes. The device met its material, assembling and product specifications. - as a possible cause of dropping off the stainless steel ring during the use, we speculate as follows: when the doctor tried to decannulate the sheath to place this device in the patient's lacrimal duct by the g-sgi technique, an excessive mechanical force was loaded to the ring mounted portion, and the ring with the bougie penetrated out of the tip of the tube.
Patient Sequence No: 1, Text Type: N, H10
[73457211]
This device (lacrifast) was employed to treat the epiphora due to lacrimal duct obstruction of a female patient. The doctor pre-opened the lacrimal duct by using a sheath. Then, he inserted one of the pair of lacrimal duct tubes into the sheath, that was pre-inserted in the lacrimal duct, by using the g-sgi (goto-sheath guided intubation) technique. While decannulating the sheath from the lacrimal duct, he felt a strong resistance. He retrieved the sheath and lacrifast out of the patient's lacrimal duct, and found 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 | 9614654-2017-00005 |
| MDR Report Key | 6515164 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-24 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-04-10 |
| Device Manufacturer Date | 2016-12-13 |
| Date Added to Maude | 2017-04-24 |
| 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 | 2017-04-24 |
| Catalog Number | LF2-R105 |
| Lot Number | KP126196 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-04-24 |