MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-10 for NORTHGATE 9360 8301444 manufactured by Northgate.
[5247]
While performing electrohydrolic lithotripsy, a 3 fr probe disintegrated in the patient's ureter. Some of the metal pieces scattered and perforated the ureter. A stent was placed in the ureter. The recommended setting on the electrohydraulic lithotripter is 65 and the hospital had the unit set at 67.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429304-1993-00157 |
| MDR Report Key | 10322 |
| Date Received | 1993-11-10 |
| Date of Report | 1993-09-27 |
| Date of Event | 1993-09-01 |
| Date Facility Aware | 1993-09-01 |
| Report Date | 1993-09-27 |
| Date Reported to FDA | 1993-09-27 |
| Date Reported to Mfgr | 1993-09-27 |
| Date Added to Maude | 1993-12-01 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | NORTHGATE |
| Generic Name | 3 FR PROBE |
| Product Code | FGM |
| Date Received | 1993-11-10 |
| Model Number | 9360 |
| Catalog Number | 8301444 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10322 |
| Manufacturer | NORTHGATE |
| Manufacturer Address | 3930 VENTURA DRIVE ARLINGTON HEIGHTS IL 60004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-11-10 |