MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-20 for ULTRASONIC TRANSDUCER 2168.50 manufactured by Richard Wolf Gmbh.
[21712048]
In the course of a kidney stone lithotripsy case, the surgeon noted that smoke was coming out of the transducer (handle) component of the ultrasound probe. This was followed by some metallic pieces of material flying out of the transducer and imbedding in the surgeon's surgical mask. Two (2) small holes were found in the material of the mask. No injury occurred. There was a piece of metal sticking out of the hard plastic case of the transducer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 401707 |
| MDR Report Key | 401707 |
| Date Received | 2002-06-20 |
| Date of Report | 2002-05-23 |
| Date of Event | 2002-05-23 |
| Date Facility Aware | 2002-05-23 |
| Report Date | 2002-06-05 |
| Date Reported to Mfgr | 2002-06-05 |
| Date Added to Maude | 2002-06-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASONIC TRANSDUCER |
| Generic Name | ULTRASONIC TRANSDUCER |
| Product Code | JOP |
| Date Received | 2002-06-20 |
| Returned To Mfg | 2002-06-04 |
| Model Number | 2168.50 |
| Catalog Number | 2168.50 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 390744 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | ULTRASONIC TRANSDUCER |
| Baseline Generic Name | ULTRASONIC TRANSDUCER |
| Baseline Model No | 2168.50 |
| Baseline Catalog No | 2168.50 |
| Baseline ID | 1039 |
| Baseline Device Family | ULTRASONIC TRANSDUCER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K820544 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-06-20 |