MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-08-01 for RUSCH MRI COND FIBER OPTIC LARYN KIT 005852300 manufactured by Teleflex.
[2777374]
The event is reported as: complaint reported as the following: "the clinicians had experienced issues with the light sources on the mri blades and handles". "the fiber bundles on the blades ranged from a loose fit to bundles that were unable to remove from the blade". The light from the blade once connected to the handle was inconsistent, and the battery was not the issue. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10090375]
The device sample was not received by the manufacturer at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2012-00096 |
| MDR Report Key | 2682471 |
| Report Source | 05,06,07 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-07-20 |
| Date of Event | 2012-07-12 |
| Date Mfgr Received | 2012-07-20 |
| Date Added to Maude | 2012-11-23 |
| 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 | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| 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 MRI COND FIBER OPTIC LARYN KIT |
| Generic Name | LARYNGOSCOPE BLADE |
| Product Code | EQN |
| Date Received | 2012-08-01 |
| Catalog Number | 005852300 |
| Lot Number | 114101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-01 |