MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-08-24 for ULTRASONIC TRANSDUCER 2168.50 manufactured by Richard Wolf Gmbh.
[19144009]
During a ureteroscopy case, the ultrasound lithotripsy transducer began to spark at the cord connection. The system was immediately shut down. No injuries occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2001-00056 |
| MDR Report Key | 349283 |
| Report Source | 05 |
| Date Received | 2001-08-24 |
| Date of Report | 2001-07-25 |
| Date of Event | 2001-07-24 |
| Date Facility Aware | 2001-07-24 |
| Report Date | 2001-07-25 |
| Date Reported to Mfgr | 2001-07-25 |
| Date Mfgr Received | 2001-07-25 |
| Device Manufacturer Date | 1996-12-01 |
| Date Added to Maude | 2001-08-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JERRY BALOK |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479131113 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASONIC TRANSDUCER |
| Generic Name | ULTRASONIC TRANSDUCER |
| Product Code | JOP |
| Date Received | 2001-08-24 |
| Returned To Mfg | 2001-07-25 |
| Model Number | 2168.50 |
| Catalog Number | 2168.50 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4.7 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 338600 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHIMER 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 | 2001-08-24 |