Model Number SR554R |
Device Problem
Break (1069)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 10/26/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
|
|
Event Description
|
It was reported that there was an issue with sr554r-injection cannula sharp 370mm ll.According to the complaint description, it was reported during total laparoscopic hysterectomy the needle tip suction sr554r broke off in patient and required a laparotomy to retrieve the tip.No patient harm was reported.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
|
|
Manufacturer Narrative
|
Investigation results: visual investigation: a pressure mark can be found at the point of the broken working end.This mark was most likely caused by an overload situation.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results the root cause of the problem is most probably usage-related.Based upon the investigations results capa is not necessary.
|
|
Search Alerts/Recalls
|