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 2014-11-03 for MICROFRANCE? INSTRUMENT 7718 manufactured by Xomed Microfrance Mfg.
[5061290]
It was reported that four loop instruments broke after their first use. Follow-up information indicates that each device was used in separate cases. The dates of each case are not known. This regulatory report is being submitted for lot 130902. The remaining loops will be submitted on three separate regulatory reports (medtronic internal reference numbers: (b)(4). The regulatory report numbers were not available at the time of submission. ). There was no injury reported as a result of each event.
Patient Sequence No: 1, Text Type: D, B5
[12547796]
No known impact or consequence to patient. (b)(4). Material fragmentation. Four devices were returned for repair/evaluation. The product analysis indicates that the loops were broken right after the laser welds. Two of the four fragments were returned. The other two were recovered and were not in contact with the patient. No material or manufacturing defect was found. The cause of the breaks could not be determined. The breaks may be a result of excessive effort during use. Result: stress problem. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00094 |
| MDR Report Key | 4219422 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-11-03 |
| Date of Report | 2014-10-07 |
| Date Mfgr Received | 2014-10-07 |
| Device Manufacturer Date | 2013-09-26 |
| Date Added to Maude | 2014-11-17 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| 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 | LOOP, WIRE |
| Product Code | JYQ |
| Date Received | 2014-11-03 |
| Returned To Mfg | 2014-10-13 |
| Model Number | 7718 |
| Catalog Number | 7718 |
| Lot Number | 130902 |
| 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 | 2014-11-03 |