MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-25 for DIVA 33300 manufactured by Karl Storz Endoscopy America.
[3153144]
During surgical procedure, upon lifting the pt's uterus with the 5mm diva tenaculum, it broke inside the pt. All broken pieces of tenaculum were retrieved. Surgery proceeded on course.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028794 |
| MDR Report Key | 2941317 |
| Date Received | 2013-01-25 |
| Date of Report | 2013-01-25 |
| Date of Event | 2013-01-17 |
| Date Added to Maude | 2013-02-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | DIVA |
| Generic Name | 5MM DIVA TENACULUM |
| Product Code | HDC |
| Date Received | 2013-01-25 |
| Model Number | 33300 |
| Lot Number | AD105 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY AMERICA |
| Manufacturer Address | 2151 EAST GRAND AVE EL SEGUNDA CA 90245501 US 90245 5017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-25 |