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Catalog Number 5955460 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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As reported, the echo ps portion of the ventralight st w/ echo ps device was inadvertently left in the patient following mesh implant; the patient underwent subsequent surgical intervention for the removal for echo ps.Based on the information provided the reported event is determined to be use related with no malfunction of the device as the instructions-for-use were not followed.Per the instructions-for-use, supplied with this device, "once initial mesh fixation is complete, the echo ps positioning system is completely removed from the body.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 information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Not returned.
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Event Description
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As reported, during a laparoscopic umbilical hernia repair procedure on (b)(6) 2022, a bard/davol ventralight st mesh w/ echo ps was implanted in the patient.As reported, when the case was completed, the or circulator identified that the echo ps was not removed from the patient.As reported, the patient was taken back into the or on the same day and the echo ps was removed without any further issue.
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Event Description
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As reported, during a laparoscopic umbilical hernia repair procedure on 05-oct-2022, a bard/davol ventralight st mesh w/ echo ps was implanted in the patient.As reported, when the case was completed, the or circulator identified that the echo ps was not removed from the patient.As reported, the patient was taken back into the or on the same day and the echo ps was removed without any further issue.
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Manufacturer Narrative
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As reported, the echo ps portion of the ventralight st w/ echo ps device was inadvertently left in the patient following mesh implant; the patient underwent subsequent surgical intervention for the removal for echo ps.Based on the information provided the reported event is determined to be use related with no malfunction of the device as the instructions-for-use were not followed.Per the instructions-for-use, supplied with this device, "once initial mesh fixation is complete, the echo ps positioning system is completely removed from the body.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.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document a correction to the annex b codes.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.
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Search Alerts/Recalls
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