MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-03-18 for RUSCH MRI CONDITIONAL FIBER-OPTIC LARYNG. KIT 005852300 manufactured by Teleflex.
[15934800]
The complaint alleges that the device will not light. The batteries were changed and device still not work. There are no reports of patient harm or injury.
Patient Sequence No: 1, Text Type: D, B5
[15956108]
The mri kit was received intact, no sign of damage to the carrying case, no signs of abuse or misuse to individual blades and handle components inside the case. All components were accounted for regarding the blades, handle, and batteries. One of the batteries that was received with the sample kit was installed into the handle. Several blades from the kit were attached to the handle and the light would not energize. The exhausted battery was removed and a fresh, known good battery was installed into the handle. Another blade was attached after the new battery was installed and the light glowed brightly with no interruptions. Each blade in the kit was attached to the handle with the new battery. The bulb glowed brightly and light was easily transferred through each of the blade fiber optics as intended for use. Based on the investigation performed, the reported complaint could not be confirmed. Two exhausted batteries were returned with the unit. The batteries are replaceable components of the kit, and are expect to be replaced periodically.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2014-00064 |
| MDR Report Key | 3847657 |
| Report Source | 06,07 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-02-26 |
| Date of Event | 2014-02-01 |
| Date Mfgr Received | 2014-03-13 |
| Date Added to Maude | 2014-06-19 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH MRI CONDITIONAL FIBER-OPTIC LARYNG. KIT |
| Generic Name | LARYNGOSCOPE KIT |
| Product Code | CAL |
| Date Received | 2014-03-18 |
| Returned To Mfg | 2014-03-05 |
| Catalog Number | 005852300 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-18 |