MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-01-09 for MICROFRANCE? INSTRUMENT MCL19 manufactured by Xomed Microfrance Mfg.
[15321889]
It was reported? The tip is bent and there is a small piece broken off.? There was no patient impact or injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[15670548]
(b)(4): the device was returned for evaluation. The analyst found the fixed jaw is broken. The fragment has not been returned. A corroded area is visible on the breakage zone. This corrosion is probably anterior to the breakage observed. Considering the age of the instrument (almost 10 years) and the observation of a corroded area anterior to the breakage, the most probable cause is a progressive weakening of the jaw during the life of the instrument (uses / constraints / shocks) which has led to the creation of micro-cracks until the reported breakage. Result? Fatigue problem. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2015-00006 |
| MDR Report Key | 4401933 |
| Report Source | 06,07 |
| Date Received | 2015-01-09 |
| Date of Report | 2014-12-18 |
| Date Mfgr Received | 2014-12-18 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2015-01-29 |
| 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 | CHARLOTTE AYALA |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328372 |
| 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 | 2015-01-09 |
| Returned To Mfg | 2014-12-30 |
| Model Number | MCL19 |
| Catalog Number | MCL19 |
| Lot Number | 05-05 |
| 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 | 2015-01-09 |