Model Number A1602 |
Device Problem
Defective Component (2292)
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Patient Problem
Not Applicable (3189)
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Event Date 02/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
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Event Description
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Complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Procedure performed: cardiac surgery.On (b)(6) 2020: during a preparation for procedure.Occurred during a pre-use inspection.S-clip did not close.Because we used other products the procedure was completed with no problem.The lot returning is unknown.[distributor] provided these 2 possible lots: lot # 1354137 or 1365527.Intervention: used other products to complete procedure.Patient status: na.
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed that the clip did not close.Based on the condition of the returned unit, it is likely that the reported event was caused by interference between the male and female jaw components.The probability and criticality of harm resulting from this failure have been evaluated and were found to be unacceptable.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has recently implemented process enhancements intended to further minimize the potential for this type of event to occur.Recall: 2027111-01/15/20-001-r.
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Event Description
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Complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Procedure performed: cardiac surgery.Hospital: [name] please see the attached report 'amr2020-01' with pictures.On (b)(6) 2020: during a preparation for procedure.Occurred during a pre-use inspection.S-clip did not close.Because we used other products the procedure was completed with no problem.Comments from [distributor]: complaint sample was returned from the hospital.The sample will be returned to applied medical.The lot returning is unknown.[distributor] provided these 2 possible lots: lot # 1354137 or 1365527.Intervention: used other products to complete procedure.Patient status: na.
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Search Alerts/Recalls
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