MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-10-21 for HOOK 165MM 2.0MM 90DEG BLUNT [MXI/XOM] MCO805 manufactured by Xomed Microfrance Mfg.
[3911083]
It was reported the distal extremity of the hook broke inside the ear canal during surgery. No reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
[11121429]
This device is used for therapeutic purposes. The batch number (lot number) of the instrument is not known but the design indicates that the instrument is at least 10 years old. (b)(4): the tip of the hook is broken. The broken fragment is missing. The observation of the breakage zone has not highlighted any manufacturing or material defects and indicates that the break has been sudden. Considering the age and the absence of manufacturing or material defect, the most probable cause is a weakening of the instrument during it years of use that has led to the breakage observed with a shock / constraint during use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2013-00487 |
| MDR Report Key | 3420610 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-10-02 |
| Date of Event | 2013-09-24 |
| Date Mfgr Received | 2013-10-02 |
| Date Added to Maude | 2014-01-23 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| 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 | HOOK 165MM 2.0MM 90DEG BLUNT [MXI/XOM] |
| Generic Name | HOOK, MICROSURGICAL EAR |
| Product Code | JYL |
| Date Received | 2013-10-21 |
| Returned To Mfg | 2013-10-02 |
| Model Number | MCO805 |
| Catalog Number | MCO805 |
| Lot Number | SEE H10 |
| 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-MONIA BOURBON-L?ARCHAMBAULT 3160 FR 3160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-21 |