MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-16 for KARL STORZ 30419 VT manufactured by Karl Storez-endoscopy America.
[19141539]
While doing gyn laparoscopic procedure tip of instrument broke off in pt. X-rays were taken & part removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 278183 |
| MDR Report Key | 278183 |
| Date Received | 2000-05-16 |
| Date of Report | 2000-05-16 |
| Date of Event | 2000-05-15 |
| Date Facility Aware | 2000-05-15 |
| Report Date | 2000-05-16 |
| Date Reported to FDA | 2000-05-16 |
| Date Reported to Mfgr | 2000-05-18 |
| Date Added to Maude | 2000-05-19 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | KARL STORZ |
| Generic Name | GRASPING FORCEPS |
| Product Code | HIM |
| Date Received | 2000-05-16 |
| Model Number | 30419 VT |
| Catalog Number | 30419 VT |
| Lot Number | GN3 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 269264 |
| Manufacturer | KARL STOREZ-ENDOSCOPY AMERICA |
| Manufacturer Address | 600 CORPORATE POINT CALVER CITY CA 902307600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-05-16 |