MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-29 for STRYKER STANDARD VIDEO CART WITH ISOLATION TRANSFORMER 0240099011 manufactured by Stryker Endoscopy-san Jose.
[34883586]
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
[34883587]
It was reported the wheel snapped off the tower.
Patient Sequence No: 1, Text Type: D, B5
[43636924]
(b)(4). This device was not received for investigation at stryker endoscopy. The device was received at tekna for evaluation. Based on the tekna service record the reported failure of "the wheel snapped off from the tower" was confirmed. According to tenka: switched to new swivel casters with precision bearings in 2007 and returned swivel caster was an older version (2006), which shows sign of customer abuse. No further action will be taken at this time because cart is over 10 years old, returned caster model is no longer used, and caster shows sign of abuse. The product was returned for investigation and the reported failure mode was confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[43636925]
It was reported the wheel snapped off the tower.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2015-01142 |
| MDR Report Key | 5333682 |
| Date Received | 2015-12-29 |
| Date of Report | 2015-12-03 |
| Date of Event | 2015-12-02 |
| Date Mfgr Received | 2015-12-03 |
| Date Added to Maude | 2015-12-29 |
| 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 | 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 | STRYKER STANDARD VIDEO CART WITH ISOLATION TRANSFORMER |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2015-12-29 |
| Returned To Mfg | 2016-01-13 |
| Catalog Number | 0240099011 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-12-29 |