MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-12 for KARL STORZ 11278AU1 manufactured by Karl Storz Endovision.
[4468939]
Allegedly, during a flexible ureteroscopy with attempted stone extraction, doctor was trying to advance scope over guide wire and perforated the ureter. A stent was placed and patient stayed overnight. Case was aborted and rescheduled one month later. The patient has made a full recovery since then.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221826-2013-00050 |
| MDR Report Key | 3751345 |
| Report Source | 05,06 |
| Date Received | 2013-12-12 |
| Date of Report | 2013-11-12 |
| Date of Event | 2013-08-14 |
| Date Mfgr Received | 2013-11-12 |
| Date Added to Maude | 2014-05-09 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSIE CHEN |
| Manufacturer Street | 2151 E GRAND AVE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ ENDOVISION |
| Manufacturer Street | 91 CARPENTER HILL RD. |
| Manufacturer City | CHARLTON MA 01507 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | FLEXIBLE URETEROSCOPE |
| Product Code | FGA |
| Date Received | 2013-12-12 |
| Model Number | 11278AU1 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOVISION |
| Manufacturer Address | CHARLTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-12 |