MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-01-22 for SURGICAL SPRING CLIPS-STEALTH, 6MM A1601 100513901 manufactured by Applied Medical Resources.
[19459443]
Pt has 3 vessel cabg. Sometime during the procedure, it was noted that a bull-dog clamp was missing. An x-ray taken intra-op indicated the clamp to be in the left chest cavity, but the surgeon couldn't remove it because he was causing damage to the incisions. Eight days later, the clamp was removed in surgery with no further problems.
Patient Sequence No: 1, Text Type: D, B5
[19712080]
The product will not be returned to the mfr. It is being held at the hosp by the risk mgmt dept. A second surgery was performed 8 days after the initial surgery to removed the spring clip. The pt is doing fine and there were not complications. 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 mfg and testing procedures. As a result, we are concluding our investigation and closing this incident life.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2007-00089 |
| MDR Report Key | 981992 |
| Report Source | 05,06 |
| Date Received | 2008-01-22 |
| Date of Report | 2007-11-30 |
| Date of Event | 2007-10-01 |
| Date Facility Aware | 2007-11-28 |
| Date Reported to FDA | 2007-10-22 |
| Date Reported to Mfgr | 2007-10-22 |
| Date Mfgr Received | 2007-11-26 |
| Date Added to Maude | 2008-01-25 |
| 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-STEALTH, 6MM |
| Generic Name | SURGICAL SPRING CLIPS |
| Product Code | DSS |
| Date Received | 2008-01-22 |
| Model Number | A1601 |
| Catalog Number | 100513901 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 951032 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | RANCHO SANTA MARGARITA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-22 |