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Model Number SIT-361-100 |
Device Problem
Defective Device (2588)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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Note: this report pertains to two of two devices used in the same procedure.It was reported to boston scientific corporation that hydra irrigation tubing and a water jet connector was used in a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, while hydra irrigation tubing was connected to a hydra water jet connector, backflow of liquid was observed.The procedure was completed using another hydra irrigation tubing and water jet connector.There was no serious injury nor adverse patient effects reported as a result of this event and the patient was reported to be stable.
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Manufacturer Narrative
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Block h6: device problem code 2588 captures the reportable backflow occurred while using the water jet connector.Block h10: one hydra water jet connector was received for analysis.A visual evaluation of the device found that the inner valve, in the connector, had shifted away from the intended location.No other issues were noted.Based on the condition of the returned device, the device would allow reflux of fluid into tubing.It is possible that the device was subjected to a higher than average pressure condition, during procedure, resulting in the valve shifting above the posts within the welded enclosure.Therefore, the most probable cause for this event is cause traced to component failure.This indicates that the issue is traced to an expected or random component failure without any design or manufacturing issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
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Event Description
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Note: this report pertains to two of two devices used in the same procedure.It was reported to boston scientific corporation that hydra irrigation tubing and a water jet connector was used in a colonoscopy procedure performed on (b)(6)2019.According to the complainant, while hydra irrigation tubing was connected to a hydra water jet connector, backflow of liquid was observed.The procedure was completed using another hydra irrigation tubing and water jet connector.There was no serious injury nor adverse patient effects reported as a result of this event and the patient was reported to be stable.
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Search Alerts/Recalls
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