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 2014-09-05 for MICROFRANCE? INSTRUMENT MCEN116 manufactured by Xomed Microfrance Mfg.
[16990815]
It was reported that upon first use, during an fess procedure, the surgeon used the forceps on the sphenoid face and the head of the forceps broke off. The customer indicated that no pieces were lost and there was no patient impact. Follow-up with the sales rep indicates that the head of the instrument that broke off is missing. However, the sales rep was informed that it was not left in the patient and confirmed that there was no patient impact. There was no injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[17192079]
(b)(4). The product analysis indicates that the distal part of the instrument is broken. The fragment was not returned, but was recovered during the operation. It is not a risk for the patient. An observation under microscope did not reveal any welding or material defects. The most probable cause of this breakage is the use of the instrument with excessive constraints on tissue that was too hard. Results: stress problem (b)(4). This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00074 |
| MDR Report Key | 4063688 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-09-05 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-08-12 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-09-18 |
| 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 | PUNCH, NASAL |
| Product Code | KAY |
| Date Received | 2014-09-05 |
| Returned To Mfg | 2014-08-26 |
| Model Number | MCEN116 |
| Catalog Number | MCEN116 |
| 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 | 2014-09-05 |