MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-08-04 for ULTRACISION HARMONIC SCALPEL HAND PIECE HP054 manufactured by Ethicon Endo Surgery, Inc..
[16153662]
Info not available, device not returned for analysis.
Patient Sequence No: 1, Text Type: N, H10
[16169460]
It was reported that during an unk procedure, the handpiece rec'd an overtemperature error. It wasn't known how the case was completed but there was no consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527736-2008-03846 |
| MDR Report Key | 1085046 |
| Report Source | 05,06,07 |
| Date Received | 2008-08-04 |
| Date of Report | 2008-06-16 |
| Date Mfgr Received | 2008-06-16 |
| Date Added to Maude | 2008-08-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON ENDO SURGERY, INC. |
| Manufacturer Street | BLVD INDEPENDENCE #1151 |
| Manufacturer City | JUAREZ CHIHUAHUA, |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACISION HARMONIC SCALPEL HAND PIECE |
| Generic Name | NONE |
| Product Code | FLF |
| Date Received | 2008-08-04 |
| Model Number | NA |
| Catalog Number | HP054 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1050064 |
| Manufacturer | ETHICON ENDO SURGERY, INC. |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-04 |