MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE B12SRT manufactured by Ethicon Endo-surgery, Inc..
[185931101]
During procedure in operating room, nurse noticed that the package had issues, it was flaking from the outside of the package. Flaking consistency was similar to white powder which could easily contaminate sterile field. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093969 |
| MDR Report Key | 9902623 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-24 |
| Date Added to Maude | 2020-03-31 |
| 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 | ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-30 |
| Model Number | B12SRT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-30 |