MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for ROSA ONE ROSAS00203 manufactured by Medtech Sa.
[188260701]
(b)(4). The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188260702]
Post registration, but prior to incision, distance sensor was being used to mark entry points on skin. Distance sensor cable was pinched in robot arm joint. The company field service engineer driver attempted to clear, but an error was detected and a shutdown and restart was necessary. Procedure proceeded normally following restart. Delay less than 5 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009185973-2020-00098 |
| MDR Report Key | 9887623 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2018-04-20 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAY SHARMA |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | MEDTECH SA |
| Manufacturer Street | ZAC EUREKA 900 RUE DU MAS DE VERCHANT |
| Manufacturer City | MONTPELLIER, LANGUEDOC-ROUSSILLON 34000 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 34000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROSA ONE |
| Generic Name | COMPUTER-ASSISTED SURGICAL DEVICE |
| Product Code | HAW |
| Date Received | 2020-03-27 |
| Model Number | ROSA ONE |
| Catalog Number | ROSAS00203 |
| Lot Number | 3.1.1.1295 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTECH SA |
| Manufacturer Address | ZAC EUREKA 900 RUE DU MAS DE VERCHANT MONTPELLIER, LANGUEDOC-ROUSSILLON 34000 FR 34000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |