MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-26 for LITHOTRITE 27076A manufactured by Karl Storz Gmbh & Co..
[26865]
Pt was scheduled for turp and bladder stone removal. Due to the size of the prostrate, suprapubic prostatectomy was planned. The jaws of the device became misaligned while in use. Surgeon was unable to realign it and procedure was converted to open surgery immediately. Pt is recovering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-1996-00006 |
| MDR Report Key | 32982 |
| Date Received | 1996-04-26 |
| Date of Report | 1996-04-16 |
| Date of Event | 1996-03-21 |
| Date Facility Aware | 1996-04-12 |
| Report Date | 1996-04-16 |
| Date Reported to FDA | 1996-04-16 |
| Date Reported to Mfgr | 1996-04-16 |
| Date Added to Maude | 1996-05-17 |
| 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 | LITHOTRITE |
| Generic Name | LITHOTRITE |
| Product Code | FGK |
| Date Received | 1996-04-26 |
| Model Number | 27076A |
| Lot Number | CQ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34281 |
| Manufacturer | KARL STORZ GMBH & CO. |
| Manufacturer Address | MITTELSTRASSE 8 POSTFACH 230 78503 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-04-26 |