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 2019-02-27 for CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX 101419701 manufactured by Applied Medical Resources.
[137362127]
The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[137362128]
Procedure performed: unknown. The perception was one of the scissors moved with difficulty which is why another sterile article was opened and used. Patient status: unknown. Type of intervention: change of device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00365 |
| MDR Report Key | 8376454 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-27 |
| Date of Report | 2019-05-16 |
| Date Mfgr Received | 2019-01-30 |
| Device Manufacturer Date | 2018-10-22 |
| Date Added to Maude | 2019-02-27 |
| 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 |
| 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 | CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX |
| Generic Name | HET |
| Product Code | HET |
| Date Received | 2019-02-27 |
| Model Number | CB030 |
| Catalog Number | 101419701 |
| Lot Number | 1339171 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-27 |