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Model Number SIT-577-15 |
Device Problem
Reflux within Device (1522)
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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 one 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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Event Description
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Note: this report pertains to one 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 1522 captures the reportable event of reflux within device.Block h10: hydra irrigation tubing was received for analysis.A visual evaluation of the returned device found no issues on any rigid or flexible tubing section, the tubing junctions or the bottle cap.A function evaluation was performed, and no issues were found.Water was injected, through the device, using a syringe to check for leaks.No leaks were noticed.Additionally, no other issues were noted.The returned device review did not show evidence of the alleged issue or any defect that could have contributed to the event.Based on all gathered information, the most probable cause of the reported event is no problem detected, which indicates that the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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Search Alerts/Recalls
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