MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-29 for CURVED INTRALUMINAL STAPLER CDH29A manufactured by Ethicon Endo-surgery.
[4907913]
Ethicon endo-surgery, curved intraluminal stapler (ils), cut the tissue but did not staple during the surgical procedure. Diagnosis or reason for use: left hemicolectomy, small bowel resection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038032 |
| MDR Report Key | 4059570 |
| Date Received | 2014-08-29 |
| Date of Report | 2014-08-28 |
| Date of Event | 2014-08-28 |
| Date Added to Maude | 2014-09-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURVED INTRALUMINAL STAPLER |
| Product Code | EEA |
| Date Received | 2014-08-29 |
| Model Number | CDH29A |
| Catalog Number | CDH29A |
| Lot Number | L4ER89 |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY |
| Manufacturer Address | GUAYNABO 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-29 |