MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for 17-001-68 manufactured by Mizuho America.
[63844135]
Aneurysm clip came off the clip applier and was believed to have flown off field. Clip was found in the brain by post-op xray. Returned to surgery the next day for removal. Clip applier instrument, device not available for eval, device has been reprocessed and reused. Device age is unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6219403 |
| MDR Report Key | 6219403 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-12-01 |
| Date Facility Aware | 2016-12-02 |
| Report Date | 2016-12-15 |
| Date Reported to FDA | 2016-12-15 |
| Date Reported to Mfgr | 2016-12-15 |
| Date Added to Maude | 2017-01-03 |
| 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 | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Generic Name | ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2016-12-15 |
| Catalog Number | 17-001-68 |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO AMERICA |
| Manufacturer Address | 30057 AHERN AVE UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-15 |