Model Number M00562651 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis; therefore, a failure 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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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-05271 for the associated device information.It was reported to boston scientific corporation that a sensation large oval med stiff snare was to be used in the fundus of the stomach during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, after the procedure began, the physician got one device and found that the sterile device pouch packaging seal was not sealed.Then they got another device from the same lot and found that the sterile device pouch packaging seal was also not sealed.The procedure was then completed with another sensation snare.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: problem code 1444 captures the reportable event of incomplete sterile packaging seal.Block h10: (product investigation) the returned sensation large oval med stiff snare was analyzed and a visual evaluation noted that the manufacturing seal of the pouch was incomplete.The reported event was confirmed.Device analysis identified that the manufacturing seal of the pouch was incomplete.An investigation was opened to further investigate the most probable cause for this issue but since the investigation is still in progress, the investigation conclusion code selected for this complaint is cause not established.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-05270 and 3005099803-2020-05271 for the associated device information.It was reported to boston scientific corporation that a sensation large oval med stiff snare was to be used in the fundus of the stomach during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, after the procedure began, the physician got one device and found that the sterile device pouch packaging seal was not sealed.Then they got another device from the same lot and found that the sterile device pouch packaging seal was also not sealed.The procedure was then completed with another sensation snare.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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