MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-07-17 for MICROFRANCE? INSTRUMENT MCO205A manufactured by Xomed Microfrance Mfg.
[4572079]
The device came in for service with the comment? Already broken.? The product analysis indicated that the tip of the hook was broken and the missing fragment was not returned.
Patient Sequence No: 1, Text Type: D, B5
[12159538]
Concomitant hook mco205b 0. 3mm 90deg anterior, 510k: exempt, lot# 140203, mfr date feb. 2014 (b)(4). The product analysis determined that for both the anterior and posterior hooks (hook mco205a 0. 3mm 90deg posterior and hook mco205b 0. 3mm 90deg anterior),? The tip of the hook is broken. The missing fragment was not returned. Considering its size (approximatively 0. 1mm), the patient risk is very low. Moreover, it appears that the event happened during the reprocessing of the instrument. The distal part of the instrument is bent. No manufacturing or material defect was found. The most probable cause of this breakage is an excessive effort during the use or the reprocessing of the instrument.? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00058 |
| MDR Report Key | 3941282 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-07-17 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-06-19 |
| Date Mfgr Received | 2014-06-24 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-07-30 |
| 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 | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328138 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROFRANCE? INSTRUMENT |
| Generic Name | HOOK, MICROSURGICAL EAR |
| Product Code | JYL |
| Date Received | 2014-07-17 |
| Returned To Mfg | 2014-06-24 |
| Model Number | MCO205A |
| Catalog Number | MCO205A |
| Lot Number | 140203 |
| 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 | 2014-07-17 |