MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for ARTICULATING ENDOSCOPIC LINEAR CUTTER ATS45 (STAPLER) manufactured by Ethicon.
[71201512]
Clamped stapler on dorsal vein, stapler would not engage. Stapler was unclamped without incident. New stapler and staple cartridge used without incident. (b)(6) rep took stapler.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068690 |
| MDR Report Key | 6438907 |
| Date Received | 2017-03-24 |
| Date of Report | 2001-03-24 |
| Date of Event | 2017-03-03 |
| Date Added to Maude | 2017-03-28 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARTICULATING ENDOSCOPIC LINEAR CUTTER |
| Generic Name | STAPLER, SURGICAL |
| Product Code | GAG |
| Date Received | 2017-03-24 |
| Returned To Mfg | 2017-03-13 |
| Model Number | ATS45 (STAPLER) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | GRANBURY TX 76048 US 76048 |
| Brand Name | ENDOPATH ETS-FLEX 45 |
| Generic Name | STAPLE |
| Product Code | NLL |
| Date Received | 2017-03-24 |
| Returned To Mfg | 2017-03-13 |
| Model Number | ETS45 (STAPLE) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | GRANBURY TX 76048 US 76048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |