MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-08-24 for BLADE EXTENDER KIT LAR-AE manufactured by Acmi.
[535996]
Patient underwent a radical prostatectomy. At this time, the anesthesiologist intubated the patient using a bullard adult intubating laryngoscope. There is an available blade extender, which is a disposable piece of plastic that fits on the blade end of the laryngoscope. It is a single use item, intended to be removed and discarded at the end of the intubation procedure. Apparently, the anesthesiologist used the blade extender and during the intubation, the extender piece became separated from the laryngoscope blade and remained in the throat of the patient. He had difficulty swallowing for several days post-operatively and underwent an upper endoscopy. The piece was removed in the operating room with some difficulty.
Patient Sequence No: 1, Text Type: D, B5
[7915845]
User facility has not made the device available for evaluation by acmi, and it is not clear at this time whether the device will be made available. Until such time, no conclusions can be drawn about this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519132-2006-00005 |
| MDR Report Key | 780518 |
| Report Source | 06 |
| Date Received | 2006-08-24 |
| Date of Report | 2006-08-24 |
| Date of Event | 2006-06-19 |
| Date Facility Aware | 2006-07-28 |
| Date Mfgr Received | 2006-07-28 |
| Date Added to Maude | 2006-11-15 |
| 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 | 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 | 2006-08-24 |
| Model Number | LAR-AE |
| Catalog Number | LAR-AE |
| Lot Number | * |
| 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 | 768296 |
| Manufacturer | ACMI |
| Manufacturer Address | * NORWALK OH * US |
| Baseline Brand Name | BLADE EXTENDER FOR BULLARD LARYNGOSCOPE |
| Baseline Generic Name | LARYNGOSCOPE |
| Baseline Model No | LAR-AE |
| Baseline Catalog No | LAR-AE |
| Baseline ID | NA |
| Baseline Device Family | LARYNGOSCOPE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K883819 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-24 |