MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-11 for STRYKERVISION FLAT-PANEL MOUNTING ARM 0240095200 manufactured by Stryker Endoscopy-san Jose.
[4957554]
It was reported that surgeon was hit on the shoulder and the nurse was hit in the face while trying to adjust the angle of the monitor.
Patient Sequence No: 1, Text Type: D, B5
[11955678]
The account in question was found to be unresponsive to all five recall notifications. Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[29874963]
The reported device was not received for investigation; therefore, the reported failure cannot be confirmed. The complaint will be closed without a detailed investigation report and based on probable root cause. In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results. Probable root cause for the reported failure involving this device could have been caused by: manufacturing nonconformity, nonconforming vesa mounting plate, weld fracture, damage during shipping /handling, missing or damaged fasteners/screws, use error. In sum, the reported failure could not be confirmed since the device was not received for investigation.
Patient Sequence No: 1, Text Type: N, H10
[29874964]
It was reported that surgeon was hit on the shoulder and the nurse was hit in the face while trying to adjust the angle of the monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2014-00589 |
| MDR Report Key | 4000392 |
| Report Source | 07 |
| Date Received | 2014-08-11 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-07-17 |
| Date Mfgr Received | 2014-07-17 |
| Date Added to Maude | 2014-08-22 |
| 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 | MR. THOMAS SHAFER |
| Manufacturer Street | 5900 OPTICAL COURT |
| 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 COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | 2936485-8/28/2013-002C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKERVISION FLAT-PANEL MOUNTING ARM |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2014-08-11 |
| Catalog Number | 0240095200 |
| 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 | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-11 |