|
Model Number 8884711253 |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
|
|
Event Description
|
Customer reports: there are some cases of enteral probes that are elbowing; some right after the passage, even if via endoscopy, and others after a few hours.
|
|
Manufacturer Narrative
|
Additional information: h4 device manufacture date has been added.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A picture was provided for evaluation.An elbowing probe can be observed; however, quality specifications and compliance of the product could not be determined from the picture alone.A physical sample is required to perform an appropriate inspection.The reported condition could not be confirmed.An investigation was conducted with the multifunctional team and the manufacturing process was reviewed.All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.The current process is running according to approved specifications.In addition, quality inspections are performed to the product for material release and production personnel perform a 100% visual inspection during the packaging process in order to detect and discard any identified problems.Should there have been a manufacturing issue it would have been detected during these process controls.It was concluded that the reported condition could not be confirmed to be generated at the manufacturing plant.No action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.
|
|
Search Alerts/Recalls
|
|
|