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Model Number 48630W |
Device Problem
Insufficient Information (3190)
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Patient Problem
Blood Loss (2597)
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Event Date 12/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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The stapler 30 white reload involved with this complaint was discarded.However, the stapler 30 instrument involved with this complaint has been returned to isi for evaluation.Upon visual and microscopic inspection, no damage was found at the wrist assembly.The instrument was placed on the system.No initialization failures or errors/faults were replicated during in-house testing.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.Clamp and fire test passed with a white stapler 30 reload.Staple formation on test sheet was proper.No lubrication at the wrist was needed.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2018.It was confirmed that the stapler 30 white reload was fired and the stapler 30 grey reload had no fire recorded.No system errors related to the stapler 30 instrument were found to have occurred during the surgical procedure.The system logs reveal that the surgeon was able to successfully clamp and showed a successful fire with a white stapler 30 reload.This complaint is being reported due to the following conclusion: during da vinci surgical procedure, it is alleged that the stapler 30 instrument misfired and the patient experienced bleeding and resulted in using a laparoscopic stapler instrument to stop the bleeding.However, at this time, the root cause of the intra-operative complication is unknown.
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Event Description
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It was initially reported that during a da vinci-assisted splenectomy procedure, it was alleged that the stapler 30 instrument misfired and caused excessive bleeding.Hence, the procedure was converted to a laparoscopic surgical procedure to stop the bleeding.On (b)(4) 2018, intuitive surgical, inc.(isi) contacted the site's robotics coordinator and obtained the following information regarding the reported event: during the procedure the surgeon was using the stapler 30 instrument with a white or grey reload on the splenic vessels.The robotics coordinator stated that the surgeon was trying to angle the stapler 30 instrument on the splenic vein or one of its branches (which were all in a messy bundle).The robotics coordinator stated that the surgeon couldn¿t articulate the stapler instrument to the angle she wanted.The robotics coordinator thought that it was a combination of the multiple structures and the angle of the instrument that contributed to the misfire of the stapler instrument that led to the bleeding.The robotics coordinator does not recall exactly how much of bleeding the patient experienced secondary to the misfire, she stated it was maybe in a few hundred range (4-500cc) and that she would check with the surgeon.The robotics coordinator did state that isi should try and follow-up with the surgeon.She also does not recall that the procedure conversion to a laparoscopic surgery was due to the issue with the stapler instrument.She stated she recalls the bleeding was resolved with a laparoscopic stapler instrument.The robotics coordinator confirmed the following: there was no tissue bunching, tissue tension, no buttress material was used, and no video recording available.The robotics coordinator stated that the reloads could have been discarded.The robotics coordinator stated that the patient had approximately 2 liters of fluid loss overall and had blood transfusion administered.The patient was in the icu post-operatively secondary to airway structural edema and confirmed that none of these complications were related to the bleeding experienced by the patient.Isi made multiple attempts to contact the surgeon; however, there was no response.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) received the reload involved with this stapler 30 complaint and completed the device evaluation.Visual inspection was conducted and the reload did not exhibit any damage or signs of a misfire.The stapler 30 grey reload had not been fired.This complaint is being reported due to the following conclusion: during da vinci surgical procedure, it is alleged that the stapler 30 instrument misfired and the patient experienced bleeding as an intra-operative complication.That resulted in conversion to laparoscopic surgical procedure to stop the bleeding.However, at this time, the root cause of the intra-operative complication is unknown.
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Search Alerts/Recalls
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