APPLIED MEDICAL RESOURCES C3001, SCOPE WARMER BOTTLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number C3001 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a damaged scope warmer bottle.The weld line at the top lip of the bottle was broken and multiple dents were observed on the bottle.Based on the condition of the returned unit, it is likely that reported event was caused by improper handling of the unit after it was shipped from applied medical.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Based upon the initial description of the event, the event was not reportable as it is unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit, applied medical determined that this event is reportable as the broken weld could compromise the sterility of the device.This report is a combined initial and follow-up report.
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Event Description
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Procedure performed: ni.Event description: translation (via deepl): defect, no function.Original: defekt, keine funktion.Today we received a call and later an email from [name] regarding a defect c3001 (lot: 1320566) and c3002 (lot: 1238952) from 1010019 [name].[name] was asked to repair these 2 products but they are fine to receive replacements instead.Intervention: before use: na.Patient status: before use: na.
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Search Alerts/Recalls
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