MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-28 for ALLIGATOR FORCEPS 30419UL manufactured by Karl Storz Endoscopy-america, Inc..
[9150]
During a laparoscopic cholecystectomy the grasping end of the forceps broke off falling into abdomen of pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002958 |
| MDR Report Key | 14935 |
| Date Received | 1994-07-28 |
| Date of Report | 1994-07-18 |
| Date of Event | 1994-07-11 |
| Date Added to Maude | 1994-07-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLIGATOR FORCEPS |
| Generic Name | GRASPER |
| Product Code | FJR |
| Date Received | 1994-07-28 |
| Catalog Number | 30419UL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14929 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | CULVER CITY CA 90232 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-28 |