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Catalog Number 5955460 |
Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Anxiety (2328); Injury (2348)
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Event Date 09/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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The echo ps positioning system which is intended to be removed from the abdomen, was not removed from the patient during the procedure as prescribed in the instructions-for-use.This complaint is confirmed as a use related event with no malfunction of the device.The warning section of the instructions-for-use states: "ventralight st mesh is the only permanent implant component of the device.The echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant." the instructions-for-use instructs the user to, "verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact after removal." once the positioning system is verified to be fully intact discard the echo ps¿ positioning system appropriately." not returned.
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Event Description
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The following was reported via maude event report mw5091719: "during the repair of umbilical hernia, ((b)(6) 2019) the echo ps positioning system ventralight mesh was used.The patient went home and was called back the next day as the surgeon suspected it was not removed.This balloon is not detectable on any imaging including x-ray, ct, or mri.An exploratory surgery needed to be performed ((b)(6) 2019).The balloon portion was left inside the patient.If there was an imaging marker on, the patient would have been taken imaging and not directly to surgery." in follow up with customer contact it is reported that the surgeon is an experienced user of the device and the patient has recuperated, however has anxiety.
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Search Alerts/Recalls
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