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Model Number FGS-0636 |
Device Problem
Failure to Calibrate (2440)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/03/2019 |
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, when the first capsule was being calibrated, the patient was placed under anesthesia.However, the first capsule failed to calibrate, and a second capsule was used, but it still failed.The physician completed esophagogastroduodenoscopy without placing the capsule and a repeat procedure was necessary.Technical support informed the customer that the capsule was calibration free.They did not have a compatible recorder for calibration free capsules.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: this report is based on information provided by medtronic investigation personnel and (b)(4) device arriving in bio lab.(b)(4) device (capsule and delivery) was received for evaluation.Since inadequate sample was returned for investigation it is impossible to determine if product meet specs or not.The visual inspection found no issues.The customer reported the first capsule failed to calibrate, and a second capsule was used, but it still failed.An investigation of the returned equipment was not performed since the sample was sent as bio-hazard contaminated to the lab and is not a bio-hazard device.Evaluation was not performed since the product sample did not arrive for investigation in a proper manner allowing investigation.The investigation could not determine a cause or a probable root cause for the customer's report based on the information provided and sample received.The bio-hazard procedure states: it is forbidden to open contaminated returned equipment outside bio lab.All parts transferred to the biohazard lab will be considered as contaminated.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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