MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for TISSUE-TEK GENIE(R) ADVANCED STAINER 8200 manufactured by Sakura Finetek Usa, Inc..
[125763197]
Sakura investigation identified that the fire was caused by an electrical short of the connectors of the station 12 photo sensor and its mating station sensor cable connector. There was no spread of fire outside of the shorted connectors. Further investigation revealed that the fire was caused by disconnection of the w1 drain line from the one-touch fitting that connects the drain lines from the station unit to the station tail. Reagent leaked onto the station unit and into the connectors. Reagent being electrically conductive, created a conductive layer between dc24v and ground (layer short). As a result, dielectric breakdown of the connectors occurred, made the insulator and connector material electrically conductive. More current then continued to flow, overheated the connectors which lead to the fire. The cause for w1 disconnecting from the one-touch fitting has been determined to be service activity for stations not draining on (b)(6) 2018. While fse (field service engineer) was at site troubleshooting the stations not draining, it was discovered that the w1/w2 lines going into the drain pan were pinched due to salt build up. Current resolution is to disconnect the w1/w2 lines and cut the tubing before the pinch. During the course of disconnecting the w1/w2 lines an excessive load was applied onto the tubing, damaged its hold mechanism of the fitting leading to disconnection of the w1 drain line. In accordance with the manufacturer's specifications, the one-touch fitting has the tensile strength of 1 mpa max. And pull-off strength of 8 n. This is considered adequate for this type of application. Based on this, it is concluded that there was no device malfunction or design deficiency. The device is safe to use.
Patient Sequence No: 1, Text Type: N, H10
[125763198]
Sakura finetek usa, inc. , received a complaint on 10/2/2018 in which customer stated that there was an error message about station 12, and he saw a flame inside the unit coming out from back of the station 12. He was able to blow them out without using a fire extinguisher. There was no damage to the patient samples, or injury to the user reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083544-2018-00006 |
| MDR Report Key | 8021854 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2018-10-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SOLMAZ SHAIDA |
| Manufacturer Street | 1750 WEST 214TH STREET |
| Manufacturer City | TORRANCE 90501 |
| Manufacturer Country | US |
| Manufacturer Postal | 90501 |
| Manufacturer Phone | 3109727800 |
| Manufacturer G1 | SAKURA FINETEK USA, INC. |
| Manufacturer Street | 1750 WEST 214TH STREET |
| Manufacturer City | TORRANCE CA 90501 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TISSUE-TEK GENIE(R) ADVANCED STAINER |
| Generic Name | GENIE |
| Product Code | KPA |
| Date Received | 2018-10-30 |
| Catalog Number | 8200 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAKURA FINETEK USA, INC. |
| Manufacturer Address | 1750 WEST 214TH STREET TORRANCE CA 90501 US 90501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-30 |