MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-07-14 for MICROFRANCE? INSTRUMENT MCO13C manufactured by Xomed Microfrance Mfg.
[18039872]
The device was returned with a request for repair. Analysis found that the mobile jaw of the instrument is missing. There was no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
[18130973]
(b)(4): product evaluation: analysis found that the mobile jaw of the instrument is missing. The fragment was not returned by the client. Considering the size of the fragment (1cm) and the type of surgery (ear microsurgery), the fragment is probably not in patient contact. The fixed jaw is badly damaged. The pin between the body and the mobile jaw is broken and its fragment is still on the forceps. The most probable cause is an excessive effort during the use or the reprocessing of the instrument. Results: fracture problem. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00056 |
| MDR Report Key | 3932078 |
| Report Source | 01,07 |
| Date Received | 2014-07-14 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-06-12 |
| Date Mfgr Received | 2014-06-19 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-07-25 |
| 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 | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2014-07-14 |
| Returned To Mfg | 2014-06-19 |
| Model Number | MCO13C |
| Catalog Number | MCO13C |
| Lot Number | 140203 |
| 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 | 2014-07-14 |