MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-11-21 for VOCAL FOLD INFUSION NEEDLE UMG 100A manufactured by Endocraft Llc..
[16165965]
The operating nurse contacted us and indicated that dr had broken a vocal fold infusion needles from its shaft while using it to inject the esophagus of a pt.
Patient Sequence No: 1, Text Type: D, B5
[16228890]
The 'vocal fold infusion needle' was designed to be used solely for the vocal fold through a direct laryngoscope and with magnification provided by a surgical microscope. For a number of reasons, it is not safe to use an angled laryngeal needle in other sites such as the esophagus, which is exactly what was done in this case. As you will note in the diagrams in the instructions-for-use that accompanied the needles, only the distal angled 3mm tip of the needle should have been penetrating the tissue so that any force-related bending should have been obvious while viewing through the surgical microscope. Therefore, the surgeon should have seen the needle if it was bending or breaking. Furthermore, even if the excessive force-related bending was missed and the needle fractured from the shaft, it should have been simple to remove the needle. Since only the distal angled aspect of the needle should have been in the soft tissue, the proximal aspect of the needle would have been easily seen emanating from the surgeon's puncture site. The operating nurse explained that she was surprised at their current scenario explaining that no one at their institution had prior difficulties with the vocal fold infusion needles. In fact, this is the first indication of a problem that endocraft has heard about.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225968-2007-00001 |
| MDR Report Key | 952063 |
| Report Source | 05 |
| Date Received | 2007-11-21 |
| Date of Report | 2007-11-20 |
| Date of Event | 2007-10-19 |
| Date Mfgr Received | 2007-10-19 |
| Device Manufacturer Date | 2007-11-02 |
| Date Added to Maude | 2008-02-29 |
| 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 | DENIIS DEVONA |
| Manufacturer Street | 3 CATALPA RD. |
| Manufacturer City | PROVIDENCE RI 02906 |
| Manufacturer Country | US |
| Manufacturer Postal | 02906 |
| Manufacturer Phone | 4014547267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOCAL FOLD INFUSION NEEDLE |
| Generic Name | LARYNGEAL INJECTING DEVICE |
| Product Code | KAA |
| Date Received | 2007-11-21 |
| Model Number | UMG 100A |
| Catalog Number | UMG 100A |
| Lot Number | 110205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 949403 |
| Manufacturer | ENDOCRAFT LLC. |
| Manufacturer Address | PROVIDENCE RI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-21 |