MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-02 for STRYKERVISION FLAT-PANEL MOUNTING ARM 0240095200 manufactured by Stryker Endoscopy San Jose.
[1168079]
It was reported that the scrub technician was adjusting the monitor and her arms were above her head. She went to put the monitor above the patient when it tilted forward, it popped out of the arm and hit her on the head. Allegedly, the technician fell and started bleeding. The technician was taken to the er for evaluation and was treated for head injury. This occurred before surgery and another cart was used.
Patient Sequence No: 1, Text Type: D, B5
[8379917]
Additional information will be provided, once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2009-00051 |
| MDR Report Key | 1398388 |
| Report Source | 07 |
| Date Received | 2009-06-02 |
| Date of Report | 2009-05-05 |
| Date of Event | 2009-05-05 |
| Date Mfgr Received | 2009-05-05 |
| Date Added to Maude | 2009-06-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NILA PATEL |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKERVISION FLAT-PANEL MOUNTING ARM |
| Generic Name | MOUNTING ARM |
| Product Code | ODA |
| Date Received | 2009-06-02 |
| Catalog Number | 0240095200 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-02 |