MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for HANA 6875 manufactured by Mizuho Orthopedic Systems, Inc..
[28511961]
Patient Sequence No: 1, Text Type: N, H10
[28511962]
A mizuho osi orthopaedic surgery table experienced a cracked connection box. It appears that the plastic box that holds the connector on the hana table easily broke. The cracks seem likely to be due to the long cable end connector that attaches to box and acts as a lever applying pressure to the box. Manufacturer response for orthopaedic surgery table, mizuho osi hana orthopaedic surgery table (per site reporter): as of this report, the manufacturer has not responded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5155768 |
| MDR Report Key | 5155768 |
| Date Received | 2015-10-16 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-09-29 |
| Report Date | 2015-09-29 |
| Date Reported to FDA | 2015-09-29 |
| Date Reported to Mfgr | 2015-09-29 |
| Date Added to Maude | 2015-10-16 |
| 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 | 3 |
| Brand Name | HANA |
| Generic Name | ORTHOPAEDIC SURGERY TABLE |
| Product Code | JEB |
| Date Received | 2015-10-16 |
| Model Number | HANA |
| Catalog Number | 6875 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-16 |