MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-04 for ENDOPATH ETS-FLEX 45 ATS45 manufactured by Ethicon Endo-surgery.
[40208546]
Ethicon endo-surgery endopath ets-flex45, articulating endoscopic linear cutter, misfired. It only stapled halfway across the intended staple line, but cut the entire length of the staple cartridge, causing the renal artery to be transected without hemostasis. Another "like" device was quickly opened and utilized for control of bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5495065 |
| MDR Report Key | 5495065 |
| Date Received | 2016-03-04 |
| Date of Report | 2016-03-02 |
| Date of Event | 2016-02-24 |
| Date Facility Aware | 2016-02-24 |
| Report Date | 2016-03-02 |
| Date Reported to FDA | 2016-03-03 |
| Date Reported to Mfgr | 2016-03-03 |
| Date Added to Maude | 2016-03-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOPATH ETS-FLEX 45 |
| Generic Name | ENDOSCOPIC STAPLER |
| Product Code | NLL |
| Date Received | 2016-03-04 |
| Model Number | ATS45 |
| Catalog Number | ATS45 |
| Lot Number | M4J04Z |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY |
| Manufacturer Address | GUAYNABO PR 00969 US 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-04 |