MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for NDS MONITOR manufactured by Nds Surgical Imaging, Llc..
[96843511]
Patient Sequence No: 1, Text Type: N, H10
[96843512]
While positioning overhead hd monitor in the operating room for a laparoscopic case, the glass became detached from the frame of the monitor, and fell to the floor and shattered. The area was contained and cleaned. The monitor was not over the sterile field and glass was not noted on the sterile field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7178070 |
| MDR Report Key | 7178070 |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-12-12 |
| Report Date | 2017-12-20 |
| Date Reported to FDA | 2017-12-20 |
| Date Reported to Mfgr | 2017-12-20 |
| Date Added to Maude | 2018-01-10 |
| 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 | NDS MONITOR |
| Generic Name | CAMERA, SURGICAL AND ACCESSORIES |
| Product Code | KQM |
| Date Received | 2018-01-10 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NDS SURGICAL IMAGING, LLC. |
| Manufacturer Address | 5750 HELLYER AVENUE SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-10 |