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 2014-12-17 for XOMED? INSTRUMENTS 3714383 manufactured by Xomed Microfrance Mfg.
[5204413]
It was reported that a 3mm gorney suction elevator broke intraoperatively during a septoplasty on (b)(6) male, (b)(6). There was no patient impact or injury reported as a result of this event and the status of the patient was reported to be? Normal.?
Patient Sequence No: 1, Text Type: D, B5
[12708075]
(b)(4). In response to medtronic? S request for device return, no device was received for evaluation. Method: no testing methods performed. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[32601385]
The following additional information was received on january 6, 2015? ? The break did not result in fragments or potential fragments inside the surgical field. ? No medical intervention was performed or required. ? The case was successfully completed using another device. The following information was received january 8, 2015? ? In response to medtronic? S request for device return, the device was received for evaluation on december 31, 2014 (detailed as follows): the suction tube was broke next to the laser weld, and the deformation at the break point indicates it was bent prior to breaking. The inner stylet was removed and was found severely bent at the edge of the knurl. The breakage appears to be consistent with customer mishandling of the product. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32601386]
Patient Sequence No: 1, Text Type: D, B5
[102626821]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00111 |
| MDR Report Key | 4338533 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2014-12-17 |
| Date of Report | 2014-11-22 |
| Date of Event | 2014-11-19 |
| Date Mfgr Received | 2015-01-06 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2014-12-31 |
| 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 | JACKLYN HAYMAN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042812769 |
| 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 | XOMED? INSTRUMENTS |
| Generic Name | ELEVATOR, ENT |
| Product Code | KAD |
| Date Received | 2014-12-17 |
| Returned To Mfg | 2014-12-31 |
| Model Number | 3714383 |
| Catalog Number | 3714383 |
| Lot Number | 140501 |
| 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 | 2014-12-17 |