MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-24 for MICROFRANCE? INSTRUMENT MCL19 manufactured by Xomed Microfrance Mfg.
[4623332]
It was reported that a tip of the forceps broke off. Repair of the device was requested. There was no injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12050418]
(b)(4). The fixed jaw is broken. The fragment was not returned by the client. No material or manufacturing defect has been found. The most probable cause of this breakage is a shock or an excessive effort during use or reprocessing of the instrument. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00060 |
| MDR Report Key | 3956066 |
| Report Source | 06 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-06-30 |
| Date of Event | 2014-06-27 |
| Date Mfgr Received | 2014-06-30 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2014-08-04 |
| 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 | 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROFRANCE? INSTRUMENT |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2014-07-24 |
| Returned To Mfg | 2014-07-22 |
| Model Number | MCL19 |
| Catalog Number | MCL19 |
| Lot Number | 200812MF |
| 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 | 2014-07-24 |