MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-14 for B & K ULTRASOUND MACHINE * manufactured by B-k Medical.
[20687267]
In surgery for rfa of liver used intraoperative ultrasound transducer on b & k ultrasound machine. Transducer was put in through plastic laparoscopy port and pulled out without being straightened which tore the skin covering on the transducer. Called b & k medical and said to send transducer and they will repair it. It will be about 6 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032710 |
| MDR Report Key | 548834 |
| Date Received | 2004-07-14 |
| Date of Report | 2004-06-04 |
| Date of Event | 2004-06-02 |
| Date Added to Maude | 2004-10-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B & K ULTRASOUND MACHINE |
| Generic Name | TRANSDUCER INTRAOPERATIVE |
| Product Code | ITY |
| Date Received | 2004-07-14 |
| Returned To Mfg | 2004-06-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 538321 |
| Manufacturer | B-K MEDICAL |
| Manufacturer Address | 250 ANDOVER ST WILMINGTON MA 01887 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-07-14 |