MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-10-27 for MICROFRANCE? INSTRUMENT MCEN116 manufactured by Xomed Microfrance Mfg.
[4982650]
It was reported that during a meatotomy, there was a? Rupture of the tip of the forceps during the intervention. Impossible to recover the tip, which remained in the left sphenoidal sinus. Obligation to perform another surgery.? The instrument broke during a second cut in a thick part of the sphenoid bone. ? This surgery [to recover the fragment] is yet to be planned. The fragment does not represent a threat for the patient's health but forbid the use of an rmi in the future. The patient is in good health.?
Patient Sequence No: 1, Text Type: D, B5
[12479509]
This device is used for therapeutic purposes. (b)(4). Product evaluation: analysis found that the tip of the active part broke from the rest of the instrument. The fragment has not been returned and could not be removed during the surgery. However, it is not a danger since the sphenoid bone makes an inert cavity. It will be removed during another surgery. An observation under microscope allowed to determine that the instrument broke on the suction tube because of a constraint in flexion. No manufacturing or material defect has been detected. The cause of this breakage cannot be determined with absolute certainty. It may come from excessive constraints due to the use on too hard tissues. The ifu nt078 stipulates that the user should not "force an instrument; breakage or failure of the instrument could occur, resulting in possible harm to the patient or user". Considering the age of the instrument - five years - this breakage may also be due to the wear of the suction tube. These elements let reasonably think that this breakage is related to the use of the instrument. Method: microscopic inspection. Results: fracture problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00088 |
| MDR Report Key | 4202848 |
| Report Source | 01,05,07 |
| Date Received | 2014-10-27 |
| Date of Report | 2014-10-09 |
| Date of Event | 2014-09-30 |
| Date Mfgr Received | 2014-10-09 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2014-10-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| 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 | 2014-10-27 |
| Returned To Mfg | 2014-10-15 |
| Model Number | MCEN116 |
| Catalog Number | MCEN116 |
| Lot Number | 07-09 |
| 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 | 1. Required No Informationntervention | 2014-10-27 |