Model Number ES89222400 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa review.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Event Description
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According to the available information, the patient experienced auto-inflation.The physician suspected the reservoir wasn't functioning properly.The reservoir was replaced and a new one was placed submuscular.
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Manufacturer Narrative
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A reservoir was received for evaluation.Examination and testing of the returned components revealed a separation in the reservoir inlet tube at the tube/strain relief junction.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be rough and irregular, indicating stress was exerted.A group of partial separations were also noted on the reservoir inlet tubing indicating contact with unshod instrumentation.Testing revealed these to not be sites of leakage.The information received indicated there was auto inflation.Testing of the returned reservoir could not confirm the auto inflation as reported.Microscopic examination of the inlet tube revealed groups of partial separations indicating contact with unshod instrument.Based on these partial separations and the rough and irregular surfaces of the separation site, it was concluded that the separation noted most likely occurred inadvertently while explanting the reservoir.Auto inflation could not occur with this separation.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.No patient injury was reported.
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Search Alerts/Recalls
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