|
Model Number SIT-355-15 |
Device Problem
Reflux within Device (1522)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/05/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
It was reported to boston scientific corporation that a hydra irrigation tubing was used in colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that a yellowish fluid had infiltrated the hydra irrigation tubing.The procedure was completed using another hydra irrigation tubing.There was no serious injury nor adverse patient effects reported as a result of this event.
|
|
Event Description
|
It was reported to boston scientific corporation that a hydra irrigation tubing was used in colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that a yellowish fluid had infiltrated the hydra irrigation tubing.The procedure was completed using another hydra irrigation tubing.There was no serious injury nor adverse patient effects reported as a result of this event.
|
|
Manufacturer Narrative
|
Device problem code 1522 captures the reportable event of reflux within device.Hydra irrigation tubing was received for analysis.A visual evaluation of the returned device found no issues on 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.
|
|
Search Alerts/Recalls
|
|
|