MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-01 for BALLENGER SWIVL KNIFE, STR BLDE RH761 manufactured by Carefusion.
[1710187]
Broke. During use in a septorhinoplasty, the involved instrument broke inside the nasal cavity. Visible pieces of the instrument were removed and intraoperative ap and lat films did not reveal any further radiopaque fragments.
Patient Sequence No: 1, Text Type: D, B5
[8764182]
The effected instrument was not received for eval; the affected instrument is crucial for a complete and accurate analysis of the concern. A review of trend reports over the last 5 yrs has revealed no previous incidents of any nature. The result of this investigation is not complete at this time. As applicable, a corrective and preventive action will be initiated once the info is collected and reviewed. A follow-up report will be submitted with the info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2010-00005 |
| MDR Report Key | 1834118 |
| Report Source | 05 |
| Date Received | 2010-09-01 |
| Date of Report | 2010-08-25 |
| Date of Event | 2010-07-13 |
| Date Mfgr Received | 2010-08-04 |
| Date Added to Maude | 2011-05-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD. |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLENGER SWIVL KNIFE, STR BLDE |
| Generic Name | KNIFE |
| Product Code | GDX |
| Date Received | 2010-09-01 |
| Model Number | RH761 |
| Catalog Number | RH761 |
| Lot Number | NO LOT GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-09-01 |