|
|
| Catalog Number 52505-12 |
| Event Date 12/19/1996 |
|
Patient Outcome
Other;
|
|
Event Description
|
During laparoscopy grasper broke off insole pt.
Able to retrieve piece.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | SEMM GRASPER |
|---|
| Type of Device | LAPAROSCOPIC INSTRUMENT |
|---|
| Baseline Device 510(K) Number | |
|---|
| Baseline Device PMA Number | |
|---|
| Manufacturer (Section F) |
| ELMED INCORP. |
| 60 fay ave |
| addison IL 60101 |
|
| Manufacturer (Section D) |
| ELMED INCORP. |
| 60 fay ave |
| addison IL 60101 |
|
| Device Event Key | 84175 |
|---|
| MDR Report Key | 84929 |
|---|
| Event Key | 79908 |
|---|
| Report Number | 84929 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | KNS |
|---|
| Report Source |
User Facility
|
|---|
| Reporter Occupation |
RISK MANAGER
|
| Type of Report
| Initial |
|---|
| Report Date |
02/01/1997 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 03/31/1997 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Is This A Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
| Device Catalogue Number | 52505-12 |
|---|
| Was Device Available For Evaluation? |
No
|
|---|
| Is The Reporter A Health Professional? |
Yes
|
|---|
| Was the Report Sent to FDA? |
Yes
|
|---|
| Distributor Facility Aware Date | 12/19/1996 |
|---|
| Device Age | 6 yr |
|---|
| Event Location |
Hospital
|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
No Answer Provided
|
|---|
|
|
Database last updated on January 30, 2009
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