MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-03-20 for EB040, OPEN FUSION DEVICE, 6/BX 101223401 manufactured by Applied Medical.
[5590943]
Gastrectomy- "after only a few seals, blade trigger started sticking and not springing back to position. Hand was latched. Surgeon did not feel safe moving forward and asked for another device. Rep mentioned that surgeon may have tried to deploy the blade while the jaws were still open. Second device (ct512) showed slight sticking of blade trigger once or twice during case so that is being cered as well. "
Patient Sequence No: 1, Text Type: D, B5
[13101247]
Ra has just 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
[23029394]
Update customer's address. Investigation summary: the event unit was returned for evaluation. Upon inspection, engineering noted that the jaws of the device were slightly misaligned. The blade lever was activated and engineering confirmed that the blade was difficult to actuate. The jaws were straightened and the blade was able to actuate smoothly. The root cause of the incident is due to variations in the welding process during manufacturing and assembly, which can cause the jaws to become slightly misaligned. Applied medical continuously seeks to improve the form, function, and ease of use of its products. As a result of this feedback, additional process and inspection steps have been added to the manufacturing process to further minimize the potential for this type of incident to occur. This document represents our final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2015-00114 |
| MDR Report Key | 4621801 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2015-02-17 |
| Date Added to Maude | 2015-04-22 |
| 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 Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 949713-823 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EB040, OPEN FUSION DEVICE, 6/BX |
| Generic Name | N/A |
| Product Code | FBQ |
| Date Received | 2015-03-20 |
| Returned To Mfg | 2015-02-19 |
| Model Number | EB040 |
| Catalog Number | 101223401 |
| Lot Number | 1239464 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-20 |