Model Number MAJ-213 |
Device Problems
Contamination (1120); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Address- (b)(6).The subject device was received and evaluated at service center olympus hong kong.Device evaluation service repair technical report (ter) provided photos of the device return , showed one (1 ) maj-213 balloon has stain in the surface and the other balloon (maj-213) has a hole.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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As reported, 1pc of maj-213 has stain in the surface and 1pc of maj-213 has a hole with lot number #18r.The issue found at preparation for use for a diagnostic procedure.There was no patient harm, no user injury reported due to the event.
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Manufacturer Narrative
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There will be no medwatch report with patient identifier (b)(6).Per the legal manufacturer, there is no potential for this issue (hole in the balloon) to cause or contribute to death or serious injury if the malfunction were to recur.
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Manufacturer Narrative
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This report is being supplemented to correct b5 and h6 of the initial report.This medwatch is being submitted for the device with a stain on the surface.
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Event Description
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As reported, 1pc of maj-213 has a stain on the surface and 1pc of maj-213 has a hole with lot number #18r.The issue found at preparation for use for a diagnostic procedure.There was no patient harm, no user injury reported due to the event.This medwatch is being submitted for the device with a stain on the surface.Medwatch with patient identifier (b)(6) is being submitted for the device with a hole.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the approved final investigation.The device history record was unable to be reviewed for this device; however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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