MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-01-23 for STRYKER 5MM X 10 FIBEROPTIC CABLE 0233-050-069 N/ manufactured by Stryker Endoscopy.
[306995]
It was reported that the unit burned the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936485-2003-00006 |
| MDR Report Key | 440041 |
| Report Source | 07 |
| Date Received | 2003-01-23 |
| Date of Report | 2003-01-16 |
| Date of Event | 2003-01-08 |
| Date Mfgr Received | 2003-01-16 |
| Date Added to Maude | 2003-01-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER 5MM X 10 FIBEROPTIC CABLE |
| Generic Name | FIBEROPTIC CABLE |
| Product Code | EQH |
| Date Received | 2003-01-23 |
| Model Number | 0233-050-069 |
| Catalog Number | N/ |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 428977 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL CT. SAN JOSE CA 95138 US |
| Baseline Brand Name | STRYKER 5MM X10 FIBEROPTIC CABLE |
| Baseline Generic Name | FIBEROPTIC CABLE |
| Baseline Model No | 0233-050-069 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-01-23 |