MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for ETHICON ENDOSCOPIC CLIP APPLIER manufactured by Ethicon Endo-surgery, Inc..
[179312760]
The dr was using this clip applier and it would not fire. A second device was opened and worked fine. No pt harm with this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092942 |
| MDR Report Key | 9699728 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-22 |
| Date Added to Maude | 2020-02-12 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHICON ENDOSCOPIC CLIP APPLIER |
| Generic Name | APPLIER, HEMOSTATIC CLIP |
| Product Code | HBT |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-01-23 |
| Lot Number | T95820 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |