MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2015-04-27 for MICROFRANCE? INSTRUMENT MCEN27-1 manufactured by Xomed Microfrance Mfg.
[5748816]
It was reported that the forceps broke during a sinus surgery. A fragment fell into the sinus and was easily removed, but led to a delay of the surgery. Additional information has been requested with no response received. There was no injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[13250955]
(b)(4). The device has not been returned. Therefore, an analysis has not been performed. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[31983138]
(b)(4). Additional information provided indicates the delay in the procedure did not result in unintended equipment. However, another procedure was necessary for the second delivery of product. The additional information was received on may 11, 2015.
Patient Sequence No: 1, Text Type: N, H10
[31983139]
Additional information provided indicates the delay in the procedure did not result in unintended equipment. However, another procedure was necessary for the second delivery of product.
Patient Sequence No: 1, Text Type: D, B5
[102626869]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2015-00039 |
| MDR Report Key | 4730690 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-04-27 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-03-27 |
| Date Mfgr Received | 2015-05-11 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2015-05-27 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 2015-04-27 |
| Model Number | MCEN27-1 |
| Catalog Number | MCEN27-1 |
| Lot Number | 03-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-04-27 |