MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-11 for ULTRASONIC TRANSDUCER 2168.50 manufactured by Richard Wolf Gmbh.
[206254]
During a stone lithotripsy procedure, the ultrasound lithotriptor transducer stopped working. Another type of lithotripsy system was then used to complete the case. No pt consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 262394 |
| MDR Report Key | 262394 |
| Date Received | 2000-02-11 |
| Date of Report | 2000-01-14 |
| Date of Event | 1999-11-19 |
| Date Facility Aware | 1999-11-19 |
| Report Date | 2000-01-04 |
| Date Reported to Mfgr | 2000-01-04 |
| Date Added to Maude | 2000-02-17 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2000-02-11 |
| Returned To Mfg | 1999-12-13 |
| Model Number | 2168.50 |
| Catalog Number | 2168.50 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 254123 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D75438 |
| 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 | 1. Other | 2000-02-11 |