MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-23 for A1801, 3/4 F SPRING CLIP 10/BX 100515901 manufactured by Applied Medical Resources.
[48823419]
Ra has received the incident device and has been assigned to engineering for evaluation. A follow-up report will be sent 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
[48823420]
Cags - "secured mammary vessel with stealth a1801, then while working on the heart noticed excessive bleeding, when checked clamp found it had broken apart. Patient is fine. " type of intervention: "the blood vessel had to be re-secured with a second clamp. " patient status- "fine. "
Patient Sequence No: 1, Text Type: D, B5
[66905269]
Investigation summary: the event unit was returned for evaluation. Upon visual inspection, engineering confirmed that the one of the jaws of the unit had broken into three pieces. Testing was performed on inventory units from the same lot, but the customer's experience was unable to be replicated. The root cause could not be confirmed as engineering was unable to replicate the customer's experience. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. In accordance with 21 cfr 803. 56, if additional information is obtained which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2016-00462 |
| MDR Report Key | 5746977 |
| Date Received | 2016-06-23 |
| Date of Report | 2017-02-01 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2016-05-25 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2016-06-23 |
| 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 Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A1801, 3/4 F SPRING CLIP 10/BX |
| Generic Name | DSS |
| Product Code | DSS |
| Date Received | 2016-06-23 |
| Returned To Mfg | 2016-06-17 |
| Model Number | A1801 |
| Catalog Number | 100515901 |
| Lot Number | 1255529 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-06-23 |