MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-29 for FLEX RETRATOR manufactured by Medrobotics Corporation.
[55908599]
Patient Sequence No: 1, Text Type: N, H10
[55908602]
Patient here for robotic assisted surgical repair of epiglottoplasty. Positioned patient's mouth open for procedure with medrobotics flex retractor by surgeons. At end of procedure when retractor was removed a small open area on chin was discovered where retractor had been against. Closed with suture by surgeons and bacitracin ointment applied. Picu rn notified. Manufacturer response for flex retractor, medrobotics flex retractor (per site reporter): the medrobotics representative is aware of the surgeon having the device at present. The representative's name can be made known to the company as needed (not available when this medsun was filed). The device was taken by the rep and used at another facility outside of our parent company in massachusetts. The company has possession of the equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5986621 |
| MDR Report Key | 5986621 |
| Date Received | 2016-09-29 |
| Date of Report | 2016-09-16 |
| Date of Event | 2016-09-08 |
| Report Date | 2016-09-14 |
| Date Reported to FDA | 2016-09-14 |
| Date Reported to Mfgr | 2016-09-14 |
| Date Added to Maude | 2016-09-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | FLEX RETRATOR |
| Generic Name | RETRACTOR, ENT - FLEX RETRACTOR |
| Product Code | KAL |
| Date Received | 2016-09-29 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDROBOTICS CORPORATION |
| Manufacturer Address | 475 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-29 |