MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 2008-01-04 for SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM G-6000 100374701 manufactured by Applied Medical Resources.
[754715]
"at the end of the procedure when the md was removing clamp from the vein graft, it fell apart into the chest cavity. " the patient has exhibited no untoward effects up to this 5th post-op day.
Patient Sequence No: 1, Text Type: D, B5
[7932108]
Add'l lot # 1021374. Product has not been returned to the manufacturer for evaluation. When product is returned, evaluation will be completed and final report will be submitted. In the absence of this subject device, it is not possible to determine the cause and failure mode. We have reviewed the device history record of this device and found no deviations or discrepancies in our standard manufacturing and testing procedures. As a result we are concluding our investigation and closing this file.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2007-00083 |
| MDR Report Key | 974052 |
| Report Source | 05,06,07,08 |
| Date Received | 2008-01-04 |
| Date of Report | 2007-11-02 |
| Date of Event | 2007-10-17 |
| Date Facility Aware | 2007-10-26 |
| Date Reported to Mfgr | 2007-10-23 |
| Date Added to Maude | 2009-04-30 |
| 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 | 0 |
| 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 |
| 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 | 2008-01-04 |
| Model Number | G-6000 |
| Catalog Number | 100374701 |
| Lot Number | 1023180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | RANCHO SANTA MARGARITA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-04 |