MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-10-14 for VAUGHN SOFT TISSUE MUSHROOM PUNCH MCEN116 manufactured by Medtronic Xomed Instrumentation S.a.s..
[2218012]
It was reported that the instrument tip became separated from the shaft upon first use. No excessive force was used. No pt injury or impact was noted.
Patient Sequence No: 1, Text Type: D, B5
[9370107]
This medwatch report is being filed after a retrospective review of service and repair returns for this product; we are filing this mdr for notification purposes. No medwatch form was received from the user facility, therefore, info on the medwatch form 3500a was completed by medtronic with info received from the reporter. Any missing or incomplete data on this form 3500a is the result of info not being provided or released by the reporter. Multiple attempts to obtain the required info were made. (b)(6). (b)(4). Product labeling indicates the device is to be used for soft tissue. Neither the device nor applicable imaging films were returned for eval, therefore, we are unable to determine the definitive cause of the reported event. A review of the device history records is not possible without add'l device info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2011-00016 |
| MDR Report Key | 2313513 |
| Report Source | 01,07 |
| Date Received | 2011-10-14 |
| Date of Report | 2010-05-05 |
| Date of Event | 2010-02-05 |
| Date Mfgr Received | 2010-02-05 |
| Date Added to Maude | 2012-07-06 |
| 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 | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042794584 |
| 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 | VAUGHN SOFT TISSUE MUSHROOM PUNCH |
| Generic Name | KAY - PUNCH NASAL |
| Product Code | KAY |
| Date Received | 2011-10-14 |
| Model Number | NA |
| Catalog Number | MCEN116 |
| Lot Number | UNK |
| 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 | RUE LE PAVILLON SAINT AUBIN LE MONIAL BOURBON L'ARCHAMBAULT 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-14 |