MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-01-23 for STORZ 10377H * manufactured by *.
[213150]
Grasper forceps tip from rigid bronchoscope broke inside esophagus with direct vision scope surgeon retrievel tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 372561 |
| MDR Report Key | 372561 |
| Date Received | 2002-01-23 |
| Date of Report | 2001-11-26 |
| Date of Event | 2001-11-14 |
| Date Reported to FDA | 2002-01-23 |
| Date Reported to Mfgr | 2002-01-23 |
| Date Added to Maude | 2002-01-24 |
| 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 | STORZ |
| Generic Name | GRASPER FOR RIGID BRONCHOSCOPE |
| Product Code | BWH |
| Date Received | 2002-01-23 |
| Model Number | 10377H |
| Catalog Number | * |
| Lot Number | * |
| ID Number | AY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 361686 |
| Manufacturer | * |
| Manufacturer Address | 3365 TREE COURT INDUSTRIAL BLVD ST LOUIS MO 631226694 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-01-23 |