MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2013-08-28 for SCISSORS MCEN216R 5MM FINE RT WORMALD [MXI] manufactured by Medtronic Xomed Instrumentation S.a.s..
[3842355]
It was reported that the tip of a scissor was broken. No other information was provided. There was no report of patient impact or in jury as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
[11187446]
(b)(4). In response to medtronic? S request for device return, no devices were received for evaluation. The device was not returned and therefore no evaluation could be performed. Method: no testing methods performed. This mdr is being filed as a result of an internal review of complaints from medtronic? S mxi facility in (b)(4). This review was conducted to resolve several issues discovered in the mxi complaint handling process. Issues resolved include the misclassification of devices returned for repair, as well as gaps in reporting. Mxi capa (b)(4) was opened to address these issues.
Patient Sequence No: 1, Text Type: N, H10
[102625574]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2013-00436 |
| MDR Report Key | 3314360 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2013-08-28 |
| Date of Report | 2011-07-19 |
| Date of Event | 2011-07-19 |
| Date Mfgr Received | 2011-07-19 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2013-11-29 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JONATHAN SCHLECH |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328355 |
| 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 MCEN216R 5MM FINE RT WORMALD [MXI] |
| Generic Name | SCISSORS, NASAL |
| Product Code | KBD |
| Date Received | 2013-08-28 |
| Model Number | MCEN216R |
| Catalog Number | MCEN216R |
| Lot Number | 201104MF1 |
| 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 INSTRUMENTATION S.A.S. |
| Manufacturer Address | LE PAVILLON SAINT-AUBIN-LE-MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-28 |