MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-14 for KARL STORZ AMERICA 33310 UM manufactured by Karl Storz America.
[1230039]
Surgeon was about to use the diva 5mm tenaculum during pt's surgery when one of the metal teeth broke off the device. The tooth was located and removed from pt with a laparoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012705 |
| MDR Report Key | 1474413 |
| Date Received | 2009-09-14 |
| Date of Report | 2009-09-14 |
| Date of Event | 2009-09-10 |
| Date Added to Maude | 2009-09-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ AMERICA |
| Generic Name | 5MM TENACULUM |
| Product Code | HDC |
| Date Received | 2009-09-14 |
| Model Number | 33310 UM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ AMERICA |
| Manufacturer Address | 2151 EAST GRAND AVE. EL SEQUNDA CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-14 |