|
|
| Catalog Number LCSC5 |
|
|
|
Event Description
|
Harmonic scalpel shears broke while inside pt.
All pieces removed.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | ETHICON |
|---|
| Type of Device | HARMONIC SCALPEL |
|---|
| Baseline Brand Name | ULTRACISION HARMONIC SCALPEL CURVED SHEARS WITH PISTOL GRIP |
|---|
| Baseline Generic Name | ULTRASONIC ACCESSORIES |
|---|
| Baseline Catalogue Number | LCSC5 |
|---|
| Baseline Device Family | ULTRACISION SURGICAL DEVICES, CURVED SHEARS, ENDO |
|---|
| Baseline Device 510(K) Number | K002981 |
|---|
| Baseline Device PMA Number | |
|---|
| Baseline Shelf Life Information |
Yes
|
|---|
| Baseline Preamendment? |
No
|
|---|
| Transitional? |
No
|
|---|
| 510(K) Exempt? |
No
|
|---|
| Shelf Life(Months) | 60 |
|---|
| Date First Marketed | 06/08/1993 |
|---|
| Manufacturer (Section D) |
| ETHICON |
| 4545 creek rd |
| cincinnatti OH 45242 2839 |
|
| Device Event Key | 517880 |
|---|
| MDR Report Key | 528688 |
|---|
| Event Key | 501873 |
|---|
| Report Number | MW1032227 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | LFL |
|---|
| Report Source |
Voluntary
|
|---|
| Report Date |
05/26/2004 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 05/26/2004 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Device Operator |
Health Professional
|
| Device Catalogue Number | LCSC5 |
|---|
| Device LOT Number | U40643 |
|---|
| Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
|---|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
No Answer Provided
|
|---|
|
|
Database last updated on December 31, 2008
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