MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-06 for WILLIAMS LACRIMAL PROBE 00-0 OP7030-300 manufactured by Carefusion.
[14867295]
Customer states instrument broke at the tip during surgery.
Patient Sequence No: 1, Text Type: D, B5
[15457606]
Your report indicated the deficiency as "instrument broke at the tip during surgery. " the effected instrument has not yet been received at our facility. A review of our dhr (device history report) and complaint history trending has been initiated. Upon receipt of the instrument it will be evaluated and forwarded on to manufacturer for an investigation into the complaint. The result of this investigation is not complete at this time, however, as soon as all info is reviewed to determine if a corrective and preventive action is necessary; a follow-up report will be submitted with the info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2009-00001 |
| MDR Report Key | 1541767 |
| Report Source | 05 |
| Date Received | 2009-11-06 |
| Date of Report | 2009-11-05 |
| Date of Event | 2009-10-08 |
| Date Mfgr Received | 2009-10-08 |
| Date Added to Maude | 2010-08-19 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD, BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CAREFUSION- V. MUELLER |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WILLIAMS LACRIMAL PROBE 00-0 |
| Generic Name | PROBE |
| Product Code | HNL |
| Date Received | 2009-11-06 |
| Model Number | OP7030-300 |
| Catalog Number | OP7030-300 |
| Lot Number | NO LOT GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2009-11-06 |