MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2015-03-31 for MICROFRANCE? INSTRUMENT MCO13C manufactured by Xomed Microfrance Mfg.
[5752313]
It was reported that an analysis was requested for? Two instruments that broke quickly after their first uses". The analysis showed that the break created fragments. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
[13100231]
Concomitant products: knife mcl59 bayonet monopolar freche, 510k: k993655, lot# 140903, mfr date: september 2014. (b)(4). The product analysis for forceps mco13c alligator 3x0. 6mm hartman found that? One of the pins of the active part is broken. There is no sign of manufacturing or material defect. The fragments of the pins are still on the instrument and so there is no risk for the patient. The most probable cause of this breakage is an impact or excessive force during the uses or the reprocessing of the instrument.? The product analysis for knife mcl59 bayonet monopolar freche, found that? The active part is broken and missing. However, the event is most likely to have occurred during the reprocessing. Moreover, the fragment is 25mm long and could not have been left unnoticed. No manufacturing or material defect was found.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2015-00028 |
| MDR Report Key | 4644048 |
| Report Source | 01,06,07 |
| Date Received | 2015-03-31 |
| Date of Report | 2015-03-05 |
| Date Mfgr Received | 2015-03-05 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-05-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328138 |
| 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 | 2015-03-31 |
| Returned To Mfg | 2015-03-05 |
| Model Number | MCO13C |
| Catalog Number | MCO13C |
| Lot Number | 150105 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-03-31 |