MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-06-04 for SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM G-6000 100374701 manufactured by Applied Medical Resources.
[638906]
"when surgeon went to remove soft jaw spring clip from pt the device broke apart and came out. Part of the plastic fell inside of chest. " pt is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[7973104]
Product has not been returned to the mfr for evaluation. If product is returned, eval will be completed and final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2007-00041 |
| MDR Report Key | 860726 |
| Report Source | 06 |
| Date Received | 2007-06-04 |
| Date of Event | 2007-05-17 |
| Date Facility Aware | 2007-05-22 |
| Date Reported to Mfgr | 2007-05-21 |
| Date Added to Maude | 2008-02-22 |
| 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 | 2007-06-04 |
| Model Number | G-6000 |
| Catalog Number | 100374701 |
| Lot Number | 1032401 |
| 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 | 959468 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | RANCHO SANTA MARGARITA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-04 |