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 2014-08-25 for MICROFRANCE? INSTRUMENT MCO205A manufactured by Xomed Microfrance Mfg.
[19373588]
Blank fields on this report are the result of information not being provided by initial reporter. This device is used for therapeutic purposes. Suspect medical device * (b)(4) instrument xomed (b)(4) instrument xomed (b)(4), (b)(4), fr 3160, model: mco205a lot: 131002, manufactured date: october 2013; suspect medical device (b)(4) instrument xomed; (b)(4), fr 3160 model: mco205b lot: 131001 manufactured date: october 2013; suspect medical device * (b)(4) instrument xomed (b)(4), fr 3160 model: mco205b lot: 131002 manufactured date: october 2013. No known impact or consequence to patient. (b)(4). Product evaluation: analysis found that on both of mco205a (2 returned), lots 131101 and 131002, the tip of the hook is broken. The missing fragment was not returned. Considering its size (approximately 0. 1mm), the patient risk is very low. Moreover, it appears that the event happened during the reprocessing of the instrument. The distal part of the instrument is bent. No manufacturing or material defect was found. The most probable cause of these breakages is an excessive effort during the use or the reprocessing of the instruments. Analysis found that on both of (b)(4) (2 returned), lots 131001 and 131002, the tip of the hook is broken. The missing fragment was not returned. Considering its size (approximately 0. 1mm), the patient risk is very low. Moreover, it appears that the event happened during the reprocessing of the instrument. The distal part of the instrument is bent. No manufacturing or material defect was found. The most probable cause of these breakages is an excessive effort during the use or the reprocessing of the instruments. Results: fracture problem; stress problem. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19480487]
It was reported that the devices were? Only used once.? Analysis found that the tips had broken and detached. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680837-2014-00071 |
| MDR Report Key | 4034644 |
| Report Source | 01,06,07 |
| Date Received | 2014-08-25 |
| Date of Report | 2014-07-31 |
| Date Mfgr Received | 2014-07-31 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-09-08 |
| 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 | HOOK, MICROSURGICAL EAR |
| Product Code | JYL |
| Date Received | 2014-08-25 |
| Returned To Mfg | 2014-08-01 |
| Model Number | MCO205A |
| Catalog Number | MCO205A |
| 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 | 2014-08-25 |