MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-05-04 for SURGICAL SPRING CLIPS-DOUBLE SOFT, 6MM G-6000 100374701 manufactured by Applied Medical Resources.
[1154722]
"end of edwards clip broke off in two small pieces, not sure if was in custom-pack or opened separately. Found all missing broken pieces. Broken clip given to charge nurse in. " it was confirmed through customer service that the device broke inside the patient.
Patient Sequence No: 1, Text Type: D, B5
[8389560]
We have contacted hospital, and are awaiting a reply to determine if product is available for evaluation. A follow-up report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2009-00032 |
| MDR Report Key | 1376467 |
| Report Source | 05,06 |
| Date Received | 2009-05-04 |
| Date of Report | 2009-04-09 |
| Date of Event | 2009-04-06 |
| Date Facility Aware | 2009-04-08 |
| Report Date | 2009-04-09 |
| Date Reported to Mfgr | 2009-04-06 |
| Date Added to Maude | 2009-10-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JAN RANK |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138237 |
| 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 | 0 |
| 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 | 2009-05-04 |
| Model Number | G-6000 |
| Catalog Number | 100374701 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Required No Informationntervention | 2009-05-04 |