FDA Adverse Event
Injury
Summary report: N
ULTRACISION HARMONIC ACE
MDR report key: 2190783
·
Received August 4, 2011
Report
- Report Number
- 3005075853-2011-03183
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- July 13, 2011
- Report Date
- July 15, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION NOT ASKED FOR BUT UNKNOWN OR PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN THE INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A THORACOSCOPIC VENTRAL SPONDYLODESES PROCEDURE, THERE WAS A RUPTURE OF THE SEGMENTAL ARTERY. LOSS OF BLOOD: 2200ML. THE PROCEDURE WAS CONVERTED TO OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC ACE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | F4PZ0P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |