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.
[63264145]
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 distal tip of the tube (colored in blue) was torn off and the stainless steel ring mounted there was missing. We observed the tube torn off surface; there were a streaky-patterned portion and remained portion with textured-pattern. The streaky-patterned is characteristic for the surface cut down by a sharp-blade like a pair of scissors, and the textured-patterned is characteristic for that torn off by strong tensile-force. From the above investigation results, we speculate that the tube was injured by something like a sharp-blade during the procedure and resulted in torn off of the distal tip by a strong tensile forth while pulling out the sheath. This report is delayed because it was sent to the emdr test instead of production.
Patient Sequence No: 1, Text Type: N, H10
[63264146]
The doctor tried to insert one of the pair of lacrimal duct tubes (colored in blue) into the lacrimal duct by the sgi (sheath guided intubation) technique. The tube was inserted through the lacrimal punctum into the sheath placed in the lacrimal duct, and the sheath was pulled out from the nasal cavity to remain the tube in the lacrimal duct. After the intubation, she checked the tube position and found the distal tip of the tube with the stainless steel ring was missing. She tried but failed to find the torn off tip of the tube and the ring in the lacrimal duct by using a dacryoendoscopy, she used a new same product and completed the operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614654-2016-00003 |
| MDR Report Key | 6203724 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-25 |
| Date of Report | 2016-01-27 |
| Date of Event | 2016-01-23 |
| Date Mfgr Received | 2016-02-02 |
| Device Manufacturer Date | 2015-09-08 |
| 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, 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 | 2016-02-02 |
| Catalog Number | LF2-R105 |
| Lot Number | KP085265 |
| Device Expiration Date | 2018-08-31 |
| 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-CITY, 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-25 |