MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-08-13 for TRACHLIGHT WAND ADULT SINGL 621100 manufactured by Laerdal Medical Corp..
[69598]
Difficult intubation (grade iv laryngoscopy). Decision for alternative means for intubation. Trach lite used without major difficulty. Breath sounds, co2 confirmed good ett placement. Pt coughed up tip of trach lite (plastic tip) on following day. Cxr negative, bronch negative for other particles. Trach lite wand was disposed of, as it is single pt use, before recognized tip was off.
Patient Sequence No: 1, Text Type: D, B5
[7766147]
The mechanical testing reported being done in the initial report has been concluded. Based on the visual inspection, and the simulated cycling, the reported trachlight lightwand tip failure experienced in the field could not be reproduced in lab testing. The failure experienced appears to be an isolated incident that was exacerbated by not using lubricant as is indicated by the directions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2425852-1997-00007 |
| MDR Report Key | 112614 |
| Report Source | 05,06 |
| Date Received | 1997-08-13 |
| Date of Report | 1997-07-14 |
| Date of Event | 1997-07-10 |
| Date Facility Aware | 1997-07-11 |
| Report Date | 1997-07-14 |
| Date Reported to Mfgr | 1997-07-14 |
| Date Mfgr Received | 1997-07-14 |
| Device Manufacturer Date | 1995-10-01 |
| Date Added to Maude | 1997-08-15 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACHLIGHT WAND |
| Generic Name | LIGHTED STYLET FOR INTUB |
| Product Code | FCQ |
| Date Received | 1997-08-13 |
| Returned To Mfg | 1997-07-22 |
| Model Number | ADULT SINGL |
| Catalog Number | 621100 |
| Lot Number | 10959 |
| ID Number | 510K# K922842/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 110547 |
| Manufacturer | LAERDAL MEDICAL CORP. |
| Manufacturer Address | 167 MYERS CORNERS RD. WAPPINGERS FALLS NY 125908840 US |
| Baseline Brand Name | TRACHLIGHT WAND |
| Baseline Generic Name | LIGHTED STYLET FOR INTUB |
| Baseline Model No | ADULT SINGL |
| Baseline Catalog No | 621100 |
| Baseline ID | 510K# K922842/A |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-13 |