Model Number CB030 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
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Event Description
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Name of procedure being performed: na (incoming inspection).Detailed description of event: [facility] incoming inspection po# 154p055.This is a complaint from aomori olympus evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: december 17, 2021.We found defects as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which returns the products.Hairlike object in pouch - cb030 lot #1431233 (1 ea.).Patient status: na (no patient involvement).Type of intervention: na (incoming inspection).
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on the condition of the returned unit and the description of the event, the hair likely originated from an operator during the manufacturing process.
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Event Description
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Name of procedure being performed: na (incoming inspection).Detailed description of event: [facility] incoming inspection po# (b)(4).This is a complaint from [facility] evaluation team.The lot mentioned above was found to have defective units per our incoming inspection.Delivery date: december 17, 2021.Please refer to the attachment file.We found defects as the result of incoming inspection of the products.Please refer to the attachment material for the quantity which returns the products.Hairlike object in pouch - cb030 lot #1431233 (1 ea.).Patient status: na (no patient involvement).Type of intervention: na (incoming inspection).
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Search Alerts/Recalls
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