Model Number M0065907051 |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/16/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The device has been received for analysis; however 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 medwatch will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation on (b)(6) 2019 that a resectr resecting device was used during a polypectomy procedure in the colon was performed on (b)(6) 2019.According to the complainant, during the procedure, the blade of the resecting device detached inside the patient while cutting and was removed using graspers.The procedure was completed with another resecting device.There were no serious injuries to the patient and the patient was reported to be fine after the procedure.
|
|
Event Description
|
It was reported to boston scientific corporation on july 16,2019 that a resectr resecting device was used during a polypectomy procedure in the colon was performed on (b)(6) 2019.According to the complainant, during the procedure, the blade of the resecting device detached inside the patient while cutting and was removed using graspers.The procedure was completed with another resecting device.There were no serious injuries to the patient and the patien was reported to be fine after the procedure.
|
|
Manufacturer Narrative
|
Block g1: mfr site email: (b)(4).Block h6: device problem code 1069 captures the reportable event resecting device blade detached and retreived.Block h10: investigation results a cannula of a resectr device was returned for investigation.The handle had been cut away from the device prior to return.Visual inspection found that the blade was with a portion jammed exterior to the cutting window.The blade damage would have likely resulted in a failure to cut during the procedure, therefore confirming the event.Review and analysis of all available information indicated that the cannula was returned with a broken blade, this was likely a result of the device being used to cut calcified tissue and the device had no influence on the event.The dfu warns the user, movement of any resectr device against resistance may result in medical device damage, tissue perforation, or other injury.Therefore, the most probable root cause is adverse event related to procedure.A dhr (device history record) review was performed and the device met all manufacturing specifications.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.
|
|
Search Alerts/Recalls
|
|