MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for ENDOPATH BLADELESS TROCAR 2B5LT manufactured by Sterilmed, Inc..
[67670225]
Patient Sequence No: 1, Text Type: N, H10
[67670226]
Valve leaks, we were unable to retain inflation of the operative area. Sleeves (2) were replaced with non-reprocessed sleeves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6338765 |
| MDR Report Key | 6338765 |
| Date Received | 2017-02-17 |
| Date of Report | 2017-02-08 |
| Date of Event | 2016-12-21 |
| Report Date | 2017-02-08 |
| Date Reported to FDA | 2017-02-08 |
| Date Reported to Mfgr | 2017-02-08 |
| Date Added to Maude | 2017-02-17 |
| 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 | 3 |
| Brand Name | ENDOPATH BLADELESS TROCAR |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2017-02-17 |
| Model Number | 2B5LT |
| Catalog Number | 2B5LT |
| Lot Number | 1915659 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE. N. SUTE 100 MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-17 |