MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-05-22 for * manufactured by Smiths Healthcare Manufacturing S.a. De C.v..
[21995671]
H6. Evaluation: a review of the instructions for use reveals that this issue is identified in both adverse reactions section and warnings. Adverse reasons: adverse reactions reported during applications esophageal stethoscopes... And tissue burns due to aberrant electro cautery radio-frequency current pathways. Warnings: during the surgical procedures which employ electro cautery, use currently acceptable procedures to minimize conditions of the thermistor and lead wires functioning as an alternate path for radio-frequency current to return to ground, causing localized tissue burns. Procedures which may minimize risk of electro-surgical burns are: keep both active and ground electrodes of the electro-cautery system in close proximity so that the sensor is outside the radio frequency current field; keep temperature monitor with its associated cables separated from electro-cautery systems. Unusual, fast artificial variations in temperature readings may occur with concomitant applications of the electro-cautery system. This report has been logged for trending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617604-2008-00065 |
| MDR Report Key | 1055527 |
| Report Source | 05,06 |
| Date Received | 2008-05-22 |
| Date Mfgr Received | 2008-04-24 |
| Date Added to Maude | 2008-06-06 |
| 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 Contact | TIM MATSON |
| Manufacturer Street | 10 BOWMAN DR |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 160 WEYMOUTH ST |
| Manufacturer City | ROCKLAND MA 02370 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02370 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | BZT |
| Date Received | 2008-05-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1023643 |
| Manufacturer | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. |
| Manufacturer Address | AVE. CALIDAD NO.4, PARQUE IND. INTERNACIONAL,OTAY UNIVERSIDAD TIJUANA, BC MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-22 |