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 EB210, VOYANT 5MM FUSION 37CM, 6/BX 101471526 manufactured by Applied Medical Resources.
[186382081]
The event unit is anticipated to returned to applied medical for evaluation. A follow-up report will be submitted upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[186382082]
Procedure performed: no information. Event description: jaws not opening. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00445 |
| MDR Report Key | 9907813 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-03 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-08-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EB210, VOYANT 5MM FUSION 37CM, 6/BX |
| Generic Name | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
| Product Code | GEI |
| Date Received | 2020-03-31 |
| Model Number | EB210 |
| Catalog Number | 101471526 |
| Lot Number | 1365182 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |