MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2011-04-15 for STRYKERVISION FLAT-PANEL MOUNTING ARM 0240095200 manufactured by Stryker Endoscopy San Jose.
[1976587]
It was reported that the customer is concerned about the safety of the product as the bolts on the mount need to be re-tightened on a monthly basis. This is done in order to hold the arm on the metal plate. When monitors are mounted on the product, they often drift into the field. The monitors have to be secured with velcro. It was further reported that the product dropped and landed on the end of the bed.
Patient Sequence No: 1, Text Type: D, B5
[9109433]
Add'l info will be provided once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2011-00236 |
| MDR Report Key | 2087301 |
| Report Source | 00,07 |
| Date Received | 2011-04-15 |
| Date of Report | 2011-03-22 |
| Date of Event | 2011-03-22 |
| Date Mfgr Received | 2011-03-22 |
| Date Added to Maude | 2011-07-11 |
| 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 | SUNNY OFFORJEBE |
| 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 | 2011-04-15 |
| Catalog Number | 0240095200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-04-15 |