Model Number CD003 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.This report is in response to medwatch report #5000510000-2020-8008.
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Event Description
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Name of procedure being performed: ni.Detailed description of event: medwatch report received by mail: mw #5000510000-2020-8008 on april 06,2020.Report is for a product problem.Date of event: (b)(6) 2019.Date of report: feb2020.Event occurred in the hospital or."bag would not deploy." device available for evaluation.Additional information received via email on 27apr2020 from [name] overlake hospital supply chain manager.This report is for two products of lot number 1333738 that experienced the same issue.No additional information provided about the event other than "bag would not deploy." the procedure was a robot procedure on (b)(6) 2019.The case was completing but using a new bag.No patient harm or injury.There are no pictures available of the complaint units.The products are available for return.Additional information received via email on 27apr2020 from [name], overlake hospital supply chain manager.Both products malfunctioned during the same case.Patient status: no patient harm or injury.Type of intervention: "new bag was opened.".
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Event Description
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Name of procedure being performed: ni.Detailed description of event: medwatch report received by mail: mw #5000510000-2020-8008 on april 06,2020.Report is for a product problem.Date of event: (b)(6) 2019.Date of report: feb 2020.Event occurred in the hospital or."bag would not deploy." device available for evaluation.Additional information received via email on 27apr2020 from [name]: this report is for two products of lot number 1333738 that experienced the same issue.No additional information provided about the event other than "bag would not deploy." the procedure was a robot procedure on (b)(6) 2019.The case was completing but using a new bag.No patient harm or injury.There are no pictures available of the complaint units.The products are available for return.Additional information received via email on 27apr2020 from [name] both products malfunctioned during the same case.Patient status: no patient harm or injury.Type of intervention: "new bag was opened.".
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Engineering was unable to deploy the bag, which confirmed the complainant's experience.Visual inspection of the event unit confirmed that the cord loop was jammed between the actuator and handle and the pawl was slightly deformed.Based on the condition of the returned unit, the event was caused by the cord loop that was jammed within the handle and actuator, which prevented the actuator from fully advancing.It is likely the complainant retracted the device then attempted to re-actuate the device in order to fully deploy the tissue bag.The instruction for use (ifu) states to "hold the inzii retrieval system in an upright position and push the thumb ring forward to deploy and advance the rim of the bag into the body cavity.The thumb ring must be pushed completely forward until it has reached its advancing endpoint, which is indicated by a stop.Do not retract prior to full deployment." the probability and critically of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report # 5000510000-2020-8008.
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Search Alerts/Recalls
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