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Model Number 48360B |
Device Problem
Failure to Form Staple (2579)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 06/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Based on the current information provided, the cause of the patient¿s post-operative complication is unknown.Isi has attempted to contact the site to gather additional information regarding the patient/incident.However, as of the date of this report, no additional information has been obtained.If additional information is received, a follow-up mdr will be submitted.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.Additionally, all instruments other than single-use instrument that were used in the case were used in subsequent procedures, and a site review shows no complaint filed against the instruments.The system logs were reviewed by an advanced failure analysis (afa) engineer and the following findings were obtained: all firings were completed per the logs with no pauses for compression on any firing.There were no incomplete clamps in the procedure.No image or video clip for the reported event was submitted for review.This complaint is reportable due to the following: based on the information available, the hole observed in the staple line is a reportable malfunction.Additionally, the placement of the drain is considered an intervention to preclude permanent impairment that was not planned as part of the procedure, and as such, is a reportable adverse event.The root cause of the customer reported failure mode cannot be determined as the instrument was discarded by the site and is not available for evaluation.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The lot number of the product was not available.Therefore the lot number and udi number are unknown.The product is not implantable.
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Event Description
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It was reported that during a da vinci-assisted sleeve gastrectomy procedure, the sureform 60 stapler was used to staple the gastric fundus when it ripped the tissue, leaving a "gaping hole" with multiple unclosed staples.The surgeon oversewed the hole multiple times and left a drain in the patient.The procedure was completed robotically.On (b)(6) 2021, intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr), who spoke to the surgeon and obtained the following information: the issue occurred with the third stapler fire, with a blue reload installed.He was informed that the issue occurred with the longer of the 2 procedures performed that day by the surgeon.The sureform stapler was fired and towards the end of the staple line, there were malformed staples and a hole was left in the staple line.The hole was oversewn with suture.The surgeon was unsure if the blade got jammed.The tissue was not dragged by the stapler, the reload was not stuck on the tissue, and it was unknown if there were any staples left in the reload pocket after it was fired.There were no tissue factors that led to the firing failure.The system did not display any error message.There was no additional excision of tissue due to the event.There was no bleeding and no blood transfusion was administered.The patient was discharged the same day with a drain inserted.The sureform stapler and reload were discarded.There was no video /images available for review.No demographic information/medical history or relevant investigation information was available.On (b)(6) 2021, isi followed up with the robotics coordinator and obtained the following information: the sureform stapler and reload had already been discarded.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
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Search Alerts/Recalls
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