MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-05-16 for 988 CAMERA CONTROL UNIT 0988010000 manufactured by Stryker Endoscopy San Jose.
[2000439]
It was reported that console shut down during the surgery. It was further reported that in the beginning, the console was functioning and monitored. The doctor then noticed the monitor had no image (black out) when he took the scope out from the sheath and inserted it again, as he needed to wipe it as it was moistured after insertion of the trocal watching the monitor. All the devices were checked and found that the console shut down (all the led/lamps/indicators on the front panel were blacked out). The called the sales rep and technical center for a backup device but it would take more than 1 hour, so the doctor explained it to the patient's family and performed an open surgery.
Patient Sequence No: 1, Text Type: D, B5
[9123622]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2011-00333 |
| MDR Report Key | 2097634 |
| Report Source | 07 |
| Date Received | 2011-05-16 |
| Date of Report | 2011-04-18 |
| Date of Event | 2011-04-15 |
| Date Mfgr Received | 2011-04-18 |
| Date Added to Maude | 2011-05-24 |
| 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 | SUNNY OFFORJEBE |
| 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 | 988 CAMERA CONTROL UNIT |
| Generic Name | CCU |
| Product Code | FXM |
| Date Received | 2011-05-16 |
| Returned To Mfg | 2011-04-27 |
| Catalog Number | 0988010000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2011-05-16 |