MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-21 for KARL STORZ ALLIGATOR FORCEPS 10378H SAME manufactured by Karl Storz Gmbh & Co..
[9171]
During bronchoscopy foreign body removal, one jaw of the forceps broke off and was not retreived.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-1994-00007 |
| MDR Report Key | 14089 |
| Date Received | 1994-03-21 |
| Date of Report | 1994-02-24 |
| Date of Event | 1994-02-18 |
| Date Facility Aware | 1994-02-22 |
| Report Date | 1994-02-24 |
| Date Reported to FDA | 1994-02-24 |
| Date Reported to Mfgr | 1994-02-24 |
| Date Added to Maude | 1994-06-18 |
| Event Key | 0 |
| Report Source Code | Distributor 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 ALLIGATOR FORCEPS |
| Generic Name | GRASPING FORCEPS |
| Product Code | JEK |
| Date Received | 1994-03-21 |
| Model Number | 10378H |
| Catalog Number | SAME |
| Lot Number | LZ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 8 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14086 |
| Manufacturer | KARL STORZ GMBH & CO. |
| Manufacturer Address | MITTELSTRASSE 8 78532 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-21 |