MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2007-05-16 for SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM G-6000 100374701 manufactured by Applied Medical Resources.
[20920595]
"dr. Applied the vascular clamp into the left internal mammary artery, when it broke into pieces. He needed to explore the chest cavity to look for the broken pieces. "
Patient Sequence No: 1, Text Type: D, B5
[21195478]
Evaluation: pieces from four or five different spring clip units were returned and visually inspected. The body female component, is the only broken component returned. Each of the returned body female components split in a different way; but most are split below where the body female snap fits with the female jaw. Conclusion/corrective action: the cause of the incident was investigated but cannot be determined without additional information. The type of clip applicator used, the amount of force applied and other factors are needed to understand the condition the clip was in. Also, since these are non-sterilized clips, the method of sterilization is unknown. Engineering was unable to duplicate the reported incident with the same model clips subjected to 1 gamma radiation sterilization cycle of 25-40kgy using a fully actuated model a3218 clip applicator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2007-00027 |
| MDR Report Key | 851165 |
| Report Source | 06,08 |
| Date Received | 2007-05-16 |
| Date of Event | 2007-02-19 |
| Date Facility Aware | 2007-04-09 |
| Date Reported to Mfgr | 2007-04-09 |
| Date Added to Maude | 2007-07-05 |
| 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 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 | 2007-05-16 |
| Returned To Mfg | 2007-04-30 |
| Model Number | G-6000 |
| Catalog Number | 100374701 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 838243 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | RANCHO SANTA MARGARITA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2007-05-16 |