MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-02-12 for BLADE EXTENDER KIT LAR-AE manufactured by Acmi Norwalk.
[17112971]
Extender blade was lost down the patient's throat during intubation. The blade was properly attached, but slipped off. The nurse noticed that the blade was missing, they searched the room for the blade but could not find it. The doctor tried to rescope the patient's esophagus and couldn't see anything. Then they brought in a flouro machine and still couldn't see anything because the item is not radiopaque. They used a long flexible scope down the patient's throat and saw the extender blade 6" - 8" down the throat. They retrieved it with a grasper and removed it.
Patient Sequence No: 1, Text Type: D, B5
[17240185]
Device has not been returned to manufacturer for analysis. At this time no conclusions can be drawn regarding the reported event. Should the device be made available for evaluation, gyrus acmi will provide an updated report to the agency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2007-00002 |
| MDR Report Key | 835056 |
| Report Source | 06,07 |
| Date Received | 2007-02-12 |
| Date Facility Aware | 2007-01-11 |
| Date Mfgr Received | 2007-01-11 |
| Date Added to Maude | 2007-04-09 |
| 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 | 0 |
| Manufacturer Contact | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | ACMI NORWALK |
| Manufacturer Street | 93 NORTH PLEASANT STREET |
| Manufacturer City | NORWALK OH 44857040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 0409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLADE EXTENDER KIT |
| Generic Name | 500 |
| Product Code | EQN |
| Date Received | 2007-02-12 |
| Model Number | LAR-AE |
| Catalog Number | LAR-AE |
| Lot Number | AG8325 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 822379 |
| Manufacturer | ACMI NORWALK |
| Manufacturer Address | * NORWALK OH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-12 |