MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-29 for ETHICON ENDO-SURGERY, LLC P30223P02 manufactured by Ethicon Endo-surgery, Llc.
[16706175]
While using the harmonic scalpel, the machine kept shutting off. Harmonic scalpel was not working. Noted that a piece of the scalpel grasper was missing. Negative x-ray. Replaced ace harmonic scalpel and patient did well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013215 |
| MDR Report Key | 1519991 |
| Date Received | 2009-10-29 |
| Date of Report | 2009-10-28 |
| Date of Event | 2009-10-27 |
| Date Added to Maude | 2009-11-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON ENDO-SURGERY, LLC |
| Generic Name | HARMONIC ACE |
| Product Code | GDX |
| Date Received | 2009-10-29 |
| Model Number | P30223P02 |
| Lot Number | FYPH182014-08 |
| ID Number | REF ACE36E |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Address | GUAYNABO PR 00969 US 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-29 |