Model Number VF608ABB |
Device Problems
Device Difficult to Setup or Prepare (1487); Human-Device Interface Problem (2949)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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Customer has been unresponsive with follow up questions.Initial complaint verbiage describes device usage that does not align with standard practice of ifu guidance.At this current time a&e medical cannot confirm the complaint.A&e medical is continuing attempts to contact the customer to gain additional information to understand the complaint.There are no similar complaints received for this product vf608abb, lot 0001u.It should be noted there is no return of product indicated at this time from the customer.(b)(4).
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Event Description
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Complaint received from customer indicates a difficulty with fixation and conductivity which led to an extended surgical time.Anecdotally customer reports other difficulties with same type of device.The complaint eludes to multiple occasions with more than one device for difficulties with fixation, conductivity and removal.
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Event Description
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Complaint received from customer indicates a difficulty with fixation and conductivity which led to an extended surgical time.Annecdotally customer reports other difficulties with same type of device.The complaint eludes to multiple occassions with more than one device for difficulties with fixation, conductivity and removal.Mdr 2242056-2019-00002 was initially written and submitted for complaint (b)(4).Subsequent communication with customer has confirmed the complaint was actually use error.The customer has been communicated to in conjunction with the instructions for use enforcing comprehension of the proper use.
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Manufacturer Narrative
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Customer has been unresponsive with follow up questions.Initial complaint verbiage describes device usage that does not align with standard practice of ifu guidance.At this current time a&e medical cannot confirm the complaint.A&e medical is continuing attempts to contact the customer to gain additional information to understand the complaint.There are no similar complaints received for this product vf608abb, lot 0001u.It should be noted there is no return of product indicated at this time from the customer.This mdr2242056-2019-00002-001 is a follow up to mdr2242056-2019-00002 submitted 4/10/2019.Subsequent communication with the customer has confirmed the root cause for the complaint was use error.There is no product deficiency.The customer has been communicated with to ensure proper use is now understood.The instructions for use were re-iterated with the customer.There continues to be no other complaints for this product.
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Search Alerts/Recalls
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