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Model Number ARD179600ML |
Device Problems
Break (1069); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
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Event Description
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On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - angenieux ax4.It was stated the plastic pivot of the fork was broken, some pieces came loose and fell off.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.
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Event Description
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On 4th january, 2024 getinge became aware of an issue with one of surgical lights - angenieux ax4.It was stated the plastic pivot of the fork was broken, some pieces came loose and fell off and that the device bearings were worn and broken.Photographic evidence indicated that bearing between fork and headlight was broken off and taped, it resulted in the headlight detaching from one side of the double fork and risk of missing particles, also the paint on the headlight was damaged with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts and particles falling off into sterile field or during procedure may cause contamination or serious injury.
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Manufacturer Narrative
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According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 4th january, 2024 getinge became aware of an issue with one of surgical lights - angenieux ax4.It was stated the plastic pivot of the fork was broken, some pieces came loose and fell off.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 4th january, 2024 getinge became aware of an issue with one of surgical lights - angenieux ax4.It was stated the plastic pivot of the fork was broken, some pieces came loose and fell off and that the device bearings were worn and broken.Photographic evidence indicated that bearing between fork and headlight was broken off and taped, it resulted in the headlight detaching from one side of the double fork and risk of missing particles, also the paint on the headlight was damaged with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts and particles falling off into sterile field or during procedure may cause contamination or serious injury.
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Search Alerts/Recalls
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