|
|
| Model Number H101 |
|
Event Type
Malfunction
|
|
Event Description
|
Customer experienced problem with replaceable tip not holding to the handle well.
Concerned that tip will fall out and cause injury.
|
| |
|
Manufacturer Narrative
|
The device returned was found to not fit securely and was determined to have insufficient crimping on the brass posts that attach to the cautery device.
The user returned another sample of the same device and same lot that had not been used.
This was inspected and was within specification and functioned as intended.
A corrective action has been implemented to determine cause of this non-conformance.
During the manufacture process the crimping device used to perform the crimping function is tested before use and samples are inspected after crimping has been performed.
No non-conformances were found during the manufacture of this device/lot.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | AARON |
|---|
| Type of Device | REPLACEMENT TIP FOR CAUTERY HANDLE |
|---|
| Baseline Brand Name | AARON MEDICAL |
|---|
| Baseline Generic Name | REPLACEABLE TIP |
|---|
| Baseline Catalogue Number | H101 |
|---|
| Baseline Device Family | NA |
|---|
| Baseline Device 510(K) Number | K841591 |
|---|
| Baseline Device PMA Number | |
|---|
| Baseline Shelf Life Information |
Yes
|
|---|
| Baseline Preamendment? |
No
|
|---|
| Transitional? |
No
|
|---|
| 510(K) Exempt? |
No
|
|---|
| Shelf Life(Months) | 48 |
|---|
| Date First Marketed | 11/01/1984 |
|---|
| Manufacturer (Section F) |
| AARON MEDICAL INDUSTRIES |
| 7100 30th ave. north |
| st. petersburg FL 33710 |
|
| Manufacturer (Section D) |
| AARON MEDICAL INDUSTRIES |
| 7100 30th ave. north |
| st. petersburg FL 33710 |
|
| Manufacturer Contact |
|
richard
kozloff
|
| 7100 30th avenue north |
| st. petersburg
, FL 33710 |
| (727)
384
-2323
|
|
| Device Event Key | 415072 |
|---|
| MDR Report Key | 426020 |
|---|
| Event Key | 403011 |
|---|
| Report Number | 1030322-2002-00015 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | GEI |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
Foreign,Distributor
|
|---|
| Reporter Occupation |
Other
|
| Type of Report
| Initial |
|---|
| Report Date |
10/03/2002 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 11/01/2002 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Is This A Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
| Device EXPIRATION Date | 05/01/2006 |
|---|
| Device MODEL Number | H101 |
|---|
| Device Catalogue Number | H101 |
|---|
| Device LOT Number | 2002-05-09 |
|---|
| OTHER Device ID Number | 0502C |
|---|
| Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
|---|
| Date Returned to Manufacturer | 10/14/2002 |
|---|
| Is The Reporter A Health Professional? |
No
|
|---|
| Was the Report Sent to FDA? |
No
|
|---|
| Date Manufacturer Received | 10/03/2002 |
|---|
| Was Device Evaluated By Manufacturer? |
Yes
|
|---|
| Date Device Manufactured | 05/01/2002 |
|---|
| Is The Device Single Use? |
Yes
|
|---|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
|
|---|
| Type of Device Usage |
Unkown
|
|---|
|
|
Database last updated on January 30, 2009
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