MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-14 for 1188HD CCU 1188010000 manufactured by Stryker Endoscopy San Jose.
[1206154]
It was reported that during a laparoscopic procedure, the image went completely green. Efforts to troubleshoot the fault by telephone, failed to resolve the problem. Allegedly, the operation would be converted to an open procedure.
Patient Sequence No: 1, Text Type: D, B5
[8145306]
Additional information will be provided once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2009-00043 |
| MDR Report Key | 1386945 |
| Report Source | 07 |
| Date Received | 2009-05-14 |
| Date of Report | 2009-04-15 |
| Date of Event | 2009-04-15 |
| Date Mfgr Received | 2009-04-15 |
| Date Added to Maude | 2009-05-26 |
| 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 | UNKNOWN |
| 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 |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1188HD CCU |
| Generic Name | CAMERA CONTROL CONSOLE |
| Product Code | FXM |
| Date Received | 2009-05-14 |
| Catalog Number | 1188010000 |
| Lot Number | 08F024914 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Other | 2009-05-14 |