MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-06 for N/A 2B5LT manufactured by Sterilmed Inc..
[64056968]
Patient Sequence No: 1, Text Type: N, H10
[64056969]
Prior to robotic transanal minimally invasive surgery, the surgeon took the device from package to use a sterile med reprocessed 5mm trocar when the top part of the device fell apart. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6228542 |
| MDR Report Key | 6228542 |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-12-06 |
| Report Date | 2016-12-21 |
| Date Reported to FDA | 2016-12-21 |
| Date Reported to Mfgr | 2016-12-21 |
| Date Added to Maude | 2017-01-06 |
| 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 |
| 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 | N/A |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2017-01-06 |
| Model Number | 2B5LT |
| Catalog Number | 2B5LT |
| Lot Number | 1960023 |
| 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. STE 100 MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-06 |