MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-02 for CLASSIC PLUS NEEDE HOLDER, STERNAL, 7 IN, 178 MM 36-2025 manufactured by Symmetry Surgical, Inc. (oem).
[113951552]
A small metal tip broke off of a needle holder used during a mitral valve repair. This was not revealed until a postoperative chest x-ray. The pt required surgical intervention to remove the retained foreign object. The device was manufactured by symmetry surgical, inc. , and serviced by (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7682519 |
| MDR Report Key | 7682519 |
| Date Received | 2018-07-02 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-06-06 |
| Date Facility Aware | 2018-06-08 |
| Report Date | 2018-06-29 |
| Date Reported to FDA | 2018-06-29 |
| Date Added to Maude | 2018-07-12 |
| 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 |
| 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 |
| Brand Name | CLASSIC PLUS NEEDE HOLDER, STERNAL, 7 IN, 178 MM |
| Generic Name | NEEDLE HOLDER / HEMOSTAT |
| Product Code | HRQ |
| Date Received | 2018-07-02 |
| Catalog Number | 36-2025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL, INC. (OEM) |
| Manufacturer Address | ANTIOCH TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-02 |