MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for VERSAONE NONB5STF manufactured by Davis & Geck Caribe Ltd.
[185750087]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185750088]
According to the reporter, pre-operatively, there was a damaged seal on all ports and a foreign substance in the package. Another device was used to complete the case. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612501-2020-00559 |
| MDR Report Key | 9902298 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-05-17 |
| Date Added to Maude | 2020-03-31 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | DAVIS & GECK CARIBE LTD |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO |
| Manufacturer City | SANTO DOMINGO 0101 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | 0101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSAONE |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-31 |
| Model Number | NONB5STF |
| Catalog Number | NONB5STF |
| Lot Number | J9E1988Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVIS & GECK CARIBE LTD |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |