MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2012-09-14 for 6MM SPRING CLIP - S/F 15/BOX G-6050 100375101 manufactured by Applied Medical.
[15508692]
Cardiac surgery with mammary artery - "while physicians were performing the mammary tear down procedure - they noticed blood in surgical field. They removed the blood and realized the clip had failed. They removed all the pieces and replaced it with another clip. "
Patient Sequence No: 1, Text Type: D, B5
[15693861]
The incident device anticipated to return. A follow-up report will be provided upon completion of investigation. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2012-00263 |
| MDR Report Key | 2750865 |
| Report Source | 04,05,06,07 |
| Date Received | 2012-09-14 |
| Date of Report | 2012-09-14 |
| Date of Event | 2012-08-02 |
| Date Facility Aware | 2012-09-04 |
| Report Date | 2012-09-14 |
| Date Added to Maude | 2012-09-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN CONTURSI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497136671 |
| Manufacturer G1 | APPLIED MEDICAL |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6MM SPRING CLIP - S/F 15/BOX |
| Generic Name | SURGICAL SPRING CLIPS |
| Product Code | DSS |
| Date Received | 2012-09-14 |
| Returned To Mfg | 2012-09-10 |
| Model Number | G-6050 |
| Catalog Number | 100375101 |
| Lot Number | 1162678 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | RANCHO SANTA MARGARITA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-14 |