MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-21 for KARL STORZ 8580BL manufactured by Karl Storz Gmbh & Co. Kg.
[18249331]
Allegedly, the doctor performed a laryngoscopic removal of vocal polyp; when they removed toweling draped around pt's face they noticed tip of nose was very white; the doctor characterized this as a minor burn. They examined the light carrier and found that an attachment pin to secure the light carrier was broken off; they think this caused light carrier/light cable to move and make contact with pt's nose. Pt is healing well.
Patient Sequence No: 1, Text Type: D, B5
[18325860]
The hospital provided a picture showing that the pin that attaches light carrier to laryngoscope was broken off; the light carrier would still work, but it would not be completely fixed to the side of the laryngoscope which resulted in the light carrier and light cable connection touching the pt's face.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2013-00006 |
| MDR Report Key | 2990051 |
| Report Source | 05,06 |
| Date Received | 2013-02-21 |
| Date of Report | 2013-02-20 |
| Date of Event | 2013-01-24 |
| Date Facility Aware | 2013-01-25 |
| Report Date | 2013-02-20 |
| Date Reported to FDA | 2013-02-20 |
| Date Reported to Mfgr | 2013-02-20 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2013-03-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | MITTELSTRASSE 8 POSTFACH 230 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | FIBER OPTIC LIGHT CARRIER |
| Product Code | EQH |
| Date Received | 2013-02-21 |
| Model Number | 8580BL |
| Catalog Number | 8580BL |
| Lot Number | OY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-02-21 |