MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for ENDO GIA 45MM TRI-STAPLE EGIA45AMT manufactured by Covidien.
[180852575]
Per operating staff, device would not click into handle. Procedure - laparoscopic appendectomy. Add'l info received from nurse mgr. "the device that malfunctioned was the reload that attaches to the insignia hand piece. Covidien endo gia 45mm tri-staple (ref # egia45amt, lot #p9d1535ky). The surgical team did open another hand piece and 45mm reload that was used on the surgical case. The malfunctioning device was not used on the pt. " fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093178 |
| MDR Report Key | 9739720 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-15 |
| Date Added to Maude | 2020-02-21 |
| 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 | ENDO GIA 45MM TRI-STAPLE |
| Generic Name | STAPLER, SURGICAL |
| Product Code | GAG |
| Date Received | 2020-02-20 |
| Model Number | EGIA45AMT |
| Lot Number | P9D1535KY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |