MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-16 for ARTICULATING ARM VP8525 manufactured by Conmed Corportation.
[77773670]
At this time conmed is awaiting receipt of the device for an evaluation. Upon the completion of the product evaluation and complaint investigation a supplemental and final report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[77773671]
The sales representative reported that the user facility contacted him on (b)(6) 2017 to report the articulating arm fell off today and landed on a nurse in the operating room. The nurse is on medical leave. Follow-up with the user facility was made on june 6, 2017. According to the nurse manager, as the nurse was removing the cover on a 40" monitor being held up by the articulating arm bracket the monitor fell off the bracket. The customer has advised that the bracket holes of the articulating arm were upside down on the plate that the screws are installed through. The nurse twisted to try to catch the monitor and wrenched her back. The nurse spent time at home with limited activity and is now fully recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2017-00060 |
| MDR Report Key | 6647465 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-16 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-05-30 |
| Date Mfgr Received | 2017-08-01 |
| Device Manufacturer Date | 2015-11-30 |
| Date Added to Maude | 2017-06-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSEY SHEPPARD |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTICULATING ARM |
| Generic Name | CAMERA, SURGICAL AND ACCESSORIES |
| Product Code | KQM |
| Date Received | 2017-06-16 |
| Returned To Mfg | 2017-07-25 |
| Catalog Number | VP8525 |
| Lot Number | 150716B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORTATION |
| Manufacturer Address | 11311 CONCEPT BOULEVARD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-16 |