BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE; DISLODGER, STONE, BASKET, URETERAL, METAL
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Model Number M0063801180 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a segura hemi basket was used in a ureteroscopic lithotripsy (ursl) procedure performed on (b)(6) 2019.According to the complainant, during preparation, a brown stain was found inside the cap of the handle and was confirmed by a photograph sent from the customer.It was noted that there was no damaged to the packaging.Another segura basket was used to complete the procedure.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Device code 2944 captures the reportable event of stain inside the cap.Visual examination of the returned device found that the handle was disassembled, and the handle cannula was detached.The indentation mark was found in the handle, indicating correct assembly of the handle cannula during manufacturing.The pull wire was found to be kinked, and a stain was observed in the handle cap and handle locator block.Further analysis was conducted for the stain found on the device.Spectral analysis of the control sample (without the stained region) found that it was a 96.72% spectral match with nylon 6/6.The sample of the stained region found a 99.08% spectral match with composite spectrum consisting of 79% control sample spectrum (without stained region) and 21% poly(ethlyleneimine).The direction for use (dfu) indicates not to disassemble the handle during preparation.The device was found to be disassembled when received, indicating that the customer removed the handle cap, which then caused the handle cannula to detach and the pull wire to become kinked.Therefore, the found failures will be documented as unintended use error caused or contributed to event since the interaction between the user and device caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.Pertaining to the reported issue of the stain found inside the cap, it was concluded that controls are in place that would prevent a unit from leaving the manufacturing facility with the cosmetic issue observed on the device; therefore, based on the information available and the analysis performed, the most probable root cause for the reported complaint will be documented as cause not established since the investigation findings cannot lead to a clear conclusion about the cause of the reported adverse event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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Event Description
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It was reported to boston scientific corporation that a segura hemi basket was used in a ureteroscopic lithotripsy (ursl) procedure performed on (b)(6) 2019.According to the complainant, during preparation, a brown stain was found inside the cap of the handle and was confirmed by a photograph sent from the customer.It was noted that there was no damaged to the packaging.Another segura basket was used to complete the procedure.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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