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Catalog Number AS-IFS1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/05/2023 |
Event Type
Injury
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Event Description
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The customer reported that the device, as-ifs1, airseal ifs, 110v, was being used during a ¿robot (da vinci) case¿ procedure on (b)(6) 2023 when it was reported, ¿during the surgery, the pneumoperitoneum stopped and the abdomen collapsed, causing the forceps inserted into the abdominal cavity to puncture the intestine.¿.After further communication with the user facility, it was found that ¿when a specimen was removed using the vaginal method, an alarm sounded to cancel air seal mode due to rapid decompression.Regarding the instrument inserted through the air seal access port is unknown but it was probably laparo forceps.The reason why the forceps stuck in the intestine could not be removed before the abdominal cavity deflated is thought to be due to damage to the intestine due to mishandling of the da vinci arm.This is not caused by the air seal.¿ a lower gastrointestinal surgeon participated in the surgery and repaired the intestinal perforation.This report is being raised due to the reported injury to patient intestines from robot da vinci arm where a conmed airseal device was used during the procedure.
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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.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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The customer reported that the device, as-ifs1, airseal ifs, 110v, was being used during a ¿robot (da vinci) case¿ procedure on (b)(6) 2023 when it was reported, ¿during the surgery, the pneumoperitoneum stopped and the abdomen collapsed, causing the forceps inserted into the abdominal cavity to puncture the intestine.¿.After further communication with the user facility, it was found that ¿when a specimen was removed using the vaginal method, an alarm sounded to cancel air seal mode due to rapid decompression.Regarding the instrument inserted through the air seal access port is unknown but it was probably laparo forceps.The reason why the forceps stuck in the intestine could not be removed before the abdominal cavity deflated is thought to be due to damage to the intestine due to mishandling of the da vinci arm.This is not caused by the air seal.¿ a lower gastrointestinal surgeon participated in the surgery and repaired the intestinal perforation.This report is being raised due to the reported injury to patient intestines from robot da vinci arm where a conmed airseal device was used during the procedure.
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Manufacturer Narrative
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The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.A device history record (dhr) review cannot be conducted as a lot number was not provided.The service history 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 23 complaints, regarding 23 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: the manufacturer strongly advises to begin the insufflation by using the veress needle for intra-abdominal and thoracic procedures.For trans-anal procedures, insufflation should be performed through a standard luer port or airseal access port.We will continue to monitor for trends through the complaint system to assure patient safety.
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Search Alerts/Recalls
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