MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2011-04-18 for 1188 HD CCU 1188010000 manufactured by Stryker Endoscopy San Jose.
[21409434]
It was reported that the unit shuts off.
Patient Sequence No: 1, Text Type: D, B5
[21482505]
The product was returned for investigation. The reported failure was confirmed. The product was subjected to functional testing. A defective integrated circuit was discovered on the main circuit board. The root cause of the reported failure was traced to this defective component. In sum, the customer complaint was confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2011-00240 |
| MDR Report Key | 2070380 |
| Report Source | 00,04 |
| Date Received | 2011-04-18 |
| Date of Report | 2011-03-25 |
| Date of Event | 2011-03-25 |
| Date Mfgr Received | 2011-03-25 |
| Date Added to Maude | 2011-10-14 |
| 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 | 1188 HD CCU |
| Generic Name | CAMERA |
| Product Code | FXM |
| Date Received | 2011-04-18 |
| Returned To Mfg | 2011-03-29 |
| Catalog Number | 1188010000 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-04-18 |