MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-01-03 for RUSCH GREENSPEC FO LARYNGOSCOPE HANDLE 004412200 manufactured by Teleflex.
[3059741]
The event is reported as: the handle to the laryngoscope would become too hot to handle when it was attached to the metal blade. The defect was discovered during testing and only when the blade was engaged with the handle. No report of user injury.
Patient Sequence No: 1, Text Type: D, B5
[10450139]
The device sample was returned for eval, but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2013-00004 |
| MDR Report Key | 2901513 |
| Report Source | 00 |
| Date Received | 2013-01-03 |
| Date of Report | 2012-12-12 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2012-12-12 |
| Date Added to Maude | 2013-03-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RESEARCH TRIANGLE PARK 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 GREENSPEC FO LARYNGOSCOPE HANDLE |
| Generic Name | FIBEROPTIC LARYNGOSCOPE HANDLE |
| Product Code | EQN |
| Date Received | 2013-01-03 |
| Returned To Mfg | 2012-12-17 |
| Catalog Number | 004412200 |
| Operator | OTHER |
| 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 | 2013-01-03 |