MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2013-03-07 for SCISSORS 3724312 EAR 3MM BLADES manufactured by Medtronic Xomed, Inc..
[3133471]
As reported, the surgeon was in the middle of a case and the tip broke off the scissor. It was also reported that there was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[10550170]
(b)(4). Method: no testing methods performed.
Patient Sequence No: 1, Text Type: N, H10
[102467730]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00227 |
| MDR Report Key | 2992856 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2013-03-07 |
| Date of Report | 2013-02-12 |
| Date of Event | 2013-02-07 |
| Date Mfgr Received | 2013-02-12 |
| Device Manufacturer Date | 2012-06-25 |
| Date Added to Maude | 2013-05-14 |
| 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 | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042798197 |
| 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 | SCISSORS 3724312 EAR 3MM BLADES |
| Generic Name | SCISSORS, EAR |
| Product Code | JZB |
| Date Received | 2013-03-07 |
| Model Number | 3724312 |
| Catalog Number | 3724312 |
| Lot Number | 201206MF3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-07 |