MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2014-09-22 for MICROFRANCE? INSTRUMENT MCEN116 manufactured by Xomed Microfrance Mfg.
[4700517]
It was reported that endoscopic sinus surgery was performed on (b)(6) 2014 and was completed with no problems as far as the or staff was concerned. On (b)(6) 2014 the patient returned for a follow up nasal endoscopic exam during which the patient reported no problems and appeared asymptomatic. On (b)(6) 2014 the patient needed to clear his throat and coughed; that? S when he discovered the little round tip of the product. On (b)(6) 2014 a ct scan without contrast was performed which provided no evidence of any additional foreign bodies. According to the facility, the current status of the patient is? Doing great.? The initial reporter informed medtronic that she has already submitted a medwatch to the fda; however, she lost the original medwatch and has recreated another medwatch for her own copies, which she sent to medtronic.
Patient Sequence No: 1, Text Type: D, B5
[12370363]
This device is used for therapeutic purposes. (b)(4). The product was not returned for analysis.
Patient Sequence No: 1, Text Type: N, H10
[24203011]
The device was returned for evaluation. The analysis was completed on march 24, 2015. The product analysis found that "the tip of the instrument is broken and there are impacts on the tube. There are no visible material or manufacturing defects. The damages on the tube indicate that the instrument was used to cut too thick and resistant tissues. " method: actual device evaluated; photographic inspection; visual inspection; labeling evaluation. Results: stress problem. Conclusion: operational context caused or contributed to event.
Patient Sequence No: 1, Text Type: N, H10
[102624107]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00078 |
| MDR Report Key | 4107388 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2014-09-22 |
| Date of Report | 2014-08-28 |
| Date of Event | 2014-08-06 |
| Date Mfgr Received | 2015-03-24 |
| Date Added to Maude | 2014-09-22 |
| 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 | 3 |
| Event Location | 3 |
| 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 | PUNCH, NASAL |
| Product Code | KAY |
| Date Received | 2014-09-22 |
| Returned To Mfg | 2015-03-13 |
| Model Number | MCEN116 |
| Catalog Number | MCEN116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2014-09-22 |