MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-07 for ADVANTAGE PLUS 1-2-510.003 manufactured by Medivators.
[178208643]
The facility reported that an employee cut their arm in the process of replacing the bottle of rapicide pa part a high level disinfectant (hld) in the automatic endoscope reprocessor (aer). The employee's right arm hit the bottom of the sheet metal divider and they received a small cut on their arm; therefore, user harm has occurred. Medivators field service engineer (fse) was dispatched to examine the machine. Medivators fse reported that a plastic cap was added to the sheet metal edge of the aer. The fse spoke with the employee who received the cut and they reported that they were fine. It was reported that the fse has never seen this happen before, and that human error may have been a factor. Medivators regulatory followed up with the facility, and they reported that the employee went to the emergency center for treatment per hospital policy. It was reported that the employee was wearing appropriate personal protective equipment (ppe), including gloves and a mask at the time of the injury. The facility reported that this type of injury has never occurred before.
Patient Sequence No: 1, Text Type: N, H10
[178208644]
The facility reported that an employee cut their arm in the process of replacing the bottle of rapicide pa part a high level disinfectant (hld) in the automatic endoscope reprocessor (aer).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2020-00005 |
| MDR Report Key | 9681492 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | LAURIE WEIR |
| Manufacturer Street | 9800 59TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7638984328 |
| Manufacturer G1 | MEDIVATORS INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTAGE PLUS |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | FEB |
| Date Received | 2020-02-07 |
| Model Number | 1-2-510.003 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |