MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-22 for MICROFRANCE? INSTRUMENT MCO5D manufactured by Xomed Microfrance Mfg.
[4725322]
It was reported that the customer requested repair of their suction knife. The tube of the instrument was broken next to the laser weld, which resulted in a device fragment. There was no reported injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[11990094]
(b)(4). The product analysis indicates that the tube of the instrument is broken next to the laser weld. No material or manufacturing defect was found. The most probable cause of the break is excessive effort during the use or the reprocessing of the instrument. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00070 |
| MDR Report Key | 4029753 |
| Report Source | 06,07 |
| Date Received | 2014-08-22 |
| Date of Report | 2014-07-30 |
| Date Mfgr Received | 2014-07-30 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-09-08 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROFRANCE? INSTRUMENT |
| Generic Name | KNIFE, EAR |
| Product Code | JYO |
| Date Received | 2014-08-22 |
| Returned To Mfg | 2014-07-30 |
| Model Number | MCO5D |
| Catalog Number | MCO5D |
| Lot Number | 131101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MICROFRANCE MFG |
| Manufacturer Address | SAINT-AUBIN-LE-MONIAL BOURBON-L'ARCHAMBAULT 3160 FR 3160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-22 |