MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-05-19 for STRYKER 5 MM FIBEROPTIC CABLE 0233-050-064 NA manufactured by Stryker Endoscopy.
[17902279]
The surgeon disconnected light cord from scope and laid it down on the pt drape for about 15 to 20 secs and pt was burned through towel and drape. Burn size about the size of a pea treated with antibiotic gel and bandaid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936485-2004-00021 |
| MDR Report Key | 563230 |
| Report Source | 07 |
| Date Received | 2004-05-19 |
| Date of Report | 2004-04-15 |
| Date of Event | 2004-03-29 |
| Report Date | 2004-03-29 |
| Date Mfgr Received | 2004-04-15 |
| Date Added to Maude | 2005-01-06 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 5900 OPTICAL CT |
| 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 5 MM FIBEROPTIC CABLE |
| Generic Name | FIBEROPTIC LIGHT CABLE |
| Product Code | EQH |
| Date Received | 2004-05-19 |
| Model Number | 0233-050-064 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 552958 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL CT. SAN JOSE CA 95138 US |
| Baseline Brand Name | STRYKER 5 MM FIBEROPTIC CABLE |
| Baseline Generic Name | FIBEROPTIC LIGHT CABLE |
| Baseline Model No | 0233-050-064 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-05-19 |