MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-21 for KARL STORZ 3891 SAME manufactured by Storz Medical Ag.
[19680074]
During stone fragmentation procedure, using a lithotripsy machine, the unit stopped working. The unit delivered 2,000 shockwaves, but there was no change in pt condition - no stones were fragmented. The unit stopped working by itself at 2,000; hosp is rescheduling pt. There was no injury to the pt or or personnel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2007-00013 |
| MDR Report Key | 974255 |
| Date Received | 2007-05-21 |
| Date of Report | 2007-05-18 |
| Date of Event | 2007-03-20 |
| Date Facility Aware | 2007-04-20 |
| Report Date | 2007-05-17 |
| Date Reported to FDA | 2007-05-18 |
| Date Reported to Mfgr | 2007-05-18 |
| Date Added to Maude | 2008-01-07 |
| 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 | 3 |
| 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 | KARL STORZ |
| Generic Name | LITHOTRIPTOR - SLX |
| Product Code | NCV |
| Date Received | 2007-05-21 |
| Model Number | 3891 |
| Catalog Number | SAME |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 942455 |
| Manufacturer | STORZ MEDICAL AG |
| Manufacturer Address | * KREUZLINGEN * SZ CH-8280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-21 |