It was reported that there was an intraoperative issue with a prestige grasper, as per information received via medwatch (b)(4).The event occurred in (b)(6) 2020.During a laparoscopic procedure, the device "broke" while in the patient's thoracic cavity.The grasper had been used to hold tissue.The piece that broke was retrieved by the surgeon.Additional details have been requested.
|
Manufacturer evaluation: the complaint device was not returned to the manufacturer for physical evaluation.However, aesculap in partnership with the contract manufacturer have previously investigated and addressed similar issues of this nature (distal brazefailure/breakage).Previous investigations performed for similar failure modes revealed the following.The supplier reviewed the work instructions (wi) for the tube sub assembly test procedure wi, the brazing procedure wi, and the brazed joint buffing wi and identified improvement opportunities.While the tube subassembly joint is 100% percent tested with a torsional force, there was no requirement for applying a bending force to the joint.Therefore, a manual bend test was added to the wi.Additionally, a review of the torque test fixture and accompanying wi, noted the potential for the tube to slip inside the collet during inspections allowing for a defective part to potentially pass this test.The tube sub assembly test procedure was further updated to note this potential failure mode and to define the process for cleaning the parts and fixture/collet with alcohol prior to use.A review of the brazing procedure wi revealed that the glass tube was too short to effectively seal the brazing area off from the surrounding environment.Without a proper seal the brazing area could have insufficient argon present to facilitate effective brazing.The brazing procedure wi was updated to include a check for this condition prior to brazing.Additionally, the supplier updated the wi to optimize the order of operations of when flux is applied, the soldering ring is assembled, and the tube is loaded.This change ensured that flux would be present throughout the entire joint space and allow for proper solder travel.Furthermore, a functional review and visual examination of the nest, which the tube sub assembly sits into, was performed.This review revealed that the two argon access holes were clogged.Therefore, the associated preventative maintenance activities were updated to monitor the access holes and prevent a recurrence of buildup.Finally, the supplier updated the brazed joint buffing wi to note the potential failure mode of excessive buffing, which could remove too much material and weaken the joint.The device history records (dhr) were not able to be reviewed as the lot number was not available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Although the complaint device was not returned for analysis, prior investigations performed for similarly reported events have confirmed this failure mode.Therefore, this event likely occurred due to inadequacies in the defined production process which limited the device performance.Therefore, the most probable root cause is considered to be manufacturing related.Aesculap inc.Opened a corrective action/preventive action (capa) for further evaluation of the design transfer of this device.
|