MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-01 for ETHICON END SURGERY, INC TX60B * manufactured by Ethicon Endo Surgery.
[15490859]
Added time to or case to abtain functional stapler.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1103837 |
| MDR Report Key | 715646 |
| Date Received | 2006-05-01 |
| Date of Report | 2006-05-01 |
| Date of Event | 2006-04-25 |
| Date Added to Maude | 2006-05-19 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON END SURGERY, INC |
| Generic Name | 60MM LINEAR STAPLER |
| Product Code | KOA |
| Date Received | 2006-05-01 |
| Returned To Mfg | 2006-05-01 |
| Model Number | TX60B |
| Catalog Number | * |
| Lot Number | C4DA27 |
| ID Number | * |
| Device Expiration Date | 2011-01-01 |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 704716 |
| Manufacturer | ETHICON ENDO SURGERY |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 45242 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-01 |