MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-12 for PKG; 26IN VISION ELECT HDTV SURGICAL VIEWING MONITOR 0240030960 manufactured by Stryker Endoscopy-san Jose.
[42488755]
(b)(4). The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[42488756]
It was reported the monitor fell and directly hit anesthetist and a nurse.
Patient Sequence No: 1, Text Type: D, B5
[50467551]
Gtin:(b)(4). The device manufacture date is not known at this time, device was not received for evaluation and serial number was not provided. Alleged failure: hdtv flat panel monitor fell probable root cause: display design, improper mounting, mounting mechanism breaks. Use error. The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[50467552]
It was reported the monitor fell and directly hit anesthetist and a nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2016-00355 |
| MDR Report Key | 5571585 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-12 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-03-18 |
| Date Added to Maude | 2016-04-12 |
| 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 | MR. KIMBERLY LYNCH |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PKG; 26IN VISION ELECT HDTV SURGICAL VIEWING MONITOR |
| Generic Name | CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO |
| Product Code | FWB |
| Date Received | 2016-04-12 |
| Catalog Number | 0240030960 |
| 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 | 1. Other | 2016-04-12 |