Model Number IPN049940 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/01/2022 |
Event Type
malfunction
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Event Description
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Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number was not provided.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".
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Manufacturer Narrative
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Qn# (b)(4).The customer returned one emerald rusch mac 3 blade for evaluation.The blade was returned with a rusch greenspan handle attached.The blade was visually inspected for signs of misuse/abuse/damage.Nothing atypical was noted.A dimensional inspection could not be performed on the base of the blade due to the condition of the returned device.The mac 3 blade was functionally tested with the attached greenspan handle per ifu.The ifu states, "attach blade to handle.Click in place.To switch on, pull blade up.To switch off, move blade down." the blade was not able to be detached from the handle.The blade could not be removed even with significant force applied.R & d engineering was consulted as part of this investigation.R & d confirmed that the blade was defective as it could not be separated by manual force.The customer did not provide a lot number; therefore, a device history record review was performed based upon lot numbers from the sales history data of the customer.No relevant findings were identified.The complaint is confirmed.Functional testing was performed and the blade was not able to be detached from the handle.The blade could not be removed even with significant force applied.R & d engineering was consulted as part of this investigation.R & d confirmed that the blade was defective as it could not be separated by manual force.A dhr review was performed based on the sales history with no relevant findings identified.The sample has been sent to the manufacturing site for further evaluation.Teleflex will continue to monitor and trend on complaints of this nature.
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Event Description
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Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".
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Manufacturer Narrative
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Qn#(b)(4).Further investigation was performed and the device was sent to the manufacturing site.The site has confirmed that the product is defective.The root cause was identified as manufacturing related.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.
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Search Alerts/Recalls
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