MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for V.MEULLER NERVE HOOK manufactured by Carefusion 2200, Inc..
[29325347]
Patient Sequence No: 1, Text Type: N, H10
[29325348]
Hook was passed to surgeon and inserted into operative site. During exploration of the surgical area with the instrument, the tip of the hook broke off the shaft of the instrument. The piece of metal was retrieved by the neptune suctioning device. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5180146 |
| MDR Report Key | 5180146 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-07 |
| Date of Event | 2015-09-19 |
| Report Date | 2015-10-07 |
| Date Reported to FDA | 2015-10-07 |
| Date Reported to Mfgr | 2015-10-07 |
| Date Added to Maude | 2015-10-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V.MEULLER NERVE HOOK |
| Generic Name | INSTRUMENT, MICROSURGICAL |
| Product Code | GZX |
| Date Received | 2015-10-27 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC. |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-27 |