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Catalog Number AS-IFS1 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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This complaint was created due to the receipt of a legal notice received on 19dec22.The device as-ifs1, airseal ifs, 110v was reported as having been used during a procedure where ¿airseal ifs made an unfamiliar noise¿ and the surgeon converted the procedure to laparotomy.This was during a robot-assisted laparoscopic supracervical hysterectomy procedure that occurred on 12aug19.This report is being raised on the basis of injury due to converting to laparotomy.
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Manufacturer Narrative
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The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history could not be performed since a serial number was not provided.A device history record review cannot be conducted as a serial number was not provided.A two-year review of complaint history revealed there has been a total of 1 report, regarding 1 device, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following: press the on/off switch.The device now initializes and then runs the initial self-test.The start screen and a progress bar are depicted on the display during the initial self-test.If the initial self-test was unsuccessful, an error message and information about how to possibly remedy the problem are displayed.An acoustic warning signal is emitted.We will continue to monitor for trends through the complaint system to assure patient safety.
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Event Description
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This complaint was created due to the receipt of a legal notice received on 19dec22.The device as-ifs1, airseal ifs, 110v was reported as having been used during a procedure where ¿airseal ifs made an unfamiliar noise¿ and the surgeon converted the procedure to laparotomy.This was during a robot-assisted laparoscopic supracervical hysterectomy procedure that occurred on (b)(6) 2019.This report is being raised on the basis of injury due to converting to laparotomy.
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Search Alerts/Recalls
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