MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-28 for HOUSE STAPES CURETTE, STRONG AU12452 manufactured by Carefusion.
[1651505]
Broken tip customer states the cup end of the instrument fell in the wound. The piece was retrieved from patient.
Patient Sequence No: 1, Text Type: D, B5
[8973708]
The complete effected instrument was not received for evaluation. The complete instrument is crucial for a complete and accurate analysis of the concern. A metallurgical review of the portion received shows that the instrument had been structurally damaged previous to this use and should have been taken out of service. It is not possible to say what caused the previous damage as it may have been due to one of the following: normal wear, misused or even being dropped during a simple cleaning process. The instrument segment provided meets all applicable specifications that would indicate that the failure is not due to workmanship or materials. A review of trends over 10 years and device history has revealed no previous incidents of any nature. The result of this investigation is complete at this time. Due to the findings of this investigation, a corrective and preventive action will not be initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2010-00043 |
| MDR Report Key | 1902963 |
| Report Source | 05 |
| Date Received | 2010-10-28 |
| Date of Report | 2010-10-27 |
| Date of Event | 2010-09-09 |
| Date Mfgr Received | 2010-09-09 |
| Date Added to Maude | 2011-04-21 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUSE STAPES CURETTE, STRONG |
| Generic Name | NA / JYG |
| Product Code | JYG |
| Date Received | 2010-10-28 |
| Returned To Mfg | 2010-10-05 |
| Model Number | AU12452 |
| Catalog Number | AU12452 |
| Lot Number | A |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-28 |