It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, it was noticed that the first clip was deployed successfully; however, when the physician went to place a second clip, resistance was felt and the clip could not pass through the working channel of the scope.The scope was switched to a different egd scope where the second clip was able to pass through and deployed successfully.Additionally, the first clip unknowingly detached from the tissue and got stuck inside the working channel of the first scope.This was only discovered upon reprocessing of the scope, when the first clip was flushed out of the working channel of the scope.A photo was submitted by the customer showing a clip assembly and a yolk outside patient.There were no patient complications reported as a result of this event.
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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