MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-11 for STRYKERVISION FLAT-PANEL MOUNTING ARM 0240095200 manufactured by Stryker Endoscopy-san Jose.
[4056363]
It was reported that the monitor fell off the arm/tower, but there was no damage to the monitor.
Patient Sequence No: 1, Text Type: D, B5
[4894785]
It was reported that the monitor fell off the arm/tower, but there was no damage to the monitor.
Patient Sequence No: 1, Text Type: D, B5
[11486543]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[12299414]
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: missing or damaged fasteners/screws. Sales rep has confirmed that the fasteners/screws were not present at the time of incident, however correction for all the arms per action 0002936485-8/28/2013-002c was conducted after the incident. The product was not returned for investigation, so the reported failure mode was not confirmed. However, correction of the device has been documented. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002936485-2014-00009 |
| MDR Report Key | 3569176 |
| Report Source | 05 |
| Date Received | 2014-01-11 |
| Date of Report | 2013-12-19 |
| Date of Event | 2013-12-19 |
| Date Mfgr Received | 2013-12-19 |
| Date Added to Maude | 2014-04-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | 00029364858/28/2013002C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKERVISION FLAT-PANEL MOUNTING ARM |
| Generic Name | CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO |
| Product Code | FWB |
| Date Received | 2014-01-11 |
| 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 | 2014-01-11 |