MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-16 for SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM G-6000 100374701 manufactured by Applied Medical Resources.
[776094]
"two spring clips broke during the case inside the pt's chest. It broke into small pieces. "
Patient Sequence No: 1, Text Type: D, B5
[8011443]
Product has not been returned to mfr for eval. When product is returned, eval will be completed and sent to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2007-00020 |
| MDR Report Key | 955479 |
| Date Received | 2007-04-16 |
| Date of Event | 2007-01-24 |
| Date Facility Aware | 2007-03-05 |
| Date Added to Maude | 2007-11-30 |
| 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 | SUSAN NICKERSON |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138396 |
| Manufacturer G1 | APPLIED MEDICAL RESOURCES CORP. |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM |
| Generic Name | SURGICAL SPRING CLIPS |
| Product Code | DSS |
| Date Received | 2007-04-16 |
| Model Number | G-6000 |
| Catalog Number | 100374701 |
| Lot Number | 100374701 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 926085 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | * RANCHO SANTA MARGARITA CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-16 |