MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-05-21 for 1188HD CCU 1188010000 manufactured by Stryker Endoscopy San Jose.
[14871941]
It was reported that the image was shaking uncontrollably. Allegedly, add'l anesthesia had to be administered. Additionally, it was reported that a loaner console and camera head were available.
Patient Sequence No: 1, Text Type: D, B5
[15518586]
Add'l info will be provided, once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2009-00046 |
| MDR Report Key | 1458159 |
| Report Source | 04 |
| Date Received | 2009-05-21 |
| Date of Report | 2009-04-22 |
| Date of Event | 2009-04-22 |
| Date Mfgr Received | 2009-04-22 |
| Date Added to Maude | 2009-11-30 |
| 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 | NILA PATEL |
| 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 | 1188HD CCU |
| Generic Name | CCU |
| Product Code | FXM |
| Date Received | 2009-05-21 |
| Catalog Number | 1188010000 |
| Lot Number | 08K009874 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2009-05-21 |