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Model Number FGS-0313 |
Device Problems
Loss of or Failure to Bond (1068); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, they had a capsule which failed to attach.There was no harm to the patient, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.A lubricant was used to facilitate placement of the capsule.
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Manufacturer Narrative
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Corrected information: if information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information:(street1, mfr city, region, postal code), evaluation summary: it was reported that one bravo ph capsule failed to attach.One bravo ph capsule was returned and received for investigation.A review of the device history records indicated that this serial number was released meeting all specifications as manufactured.The failure reported by the user is captured in the current risk management and found acceptable.No update to the risk management file is required at this time.The device was lost after return so a full investigation could not be completed.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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