Model Number M00560150 |
Device Problems
Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/06/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental emdr will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that an injection gold probe was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the needle was not coming out outside or inside the patient.The procedure was not completed due to same device unavailable.There were no patient complications reported as a result of this event.
|
|
Manufacturer Narrative
|
Block h2: correction (e3 occupation) block h6: device problem code 3191 is being used to capture the reportable issue of procedure not completed successfully.Block h10: investigation results the returned injection gold probe needle was analyzed, and a visual evaluation noted that the device was bent in the distal part of the catheter.A functional evaluation noted that the the needle could not extend.Additionally, the needle was visually checked under x-ray and it was observed that the needle was broken inside the handle.Based on all available information and the condition of the returned device, bents or kinks in the device catheter could be caused due to procedure practices such as user technique or handling.When the working length is kinked it causes difficulty actuating and eventually the needle could be broken when the unit is actuated.The investigation concluded that the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
|
|
Event Description
|
It was reported to boston scientific corporation that an injection gold probe was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the needle was not coming out outside or inside the patient.The procedure was not completed due to same device unavailable.There were no patient complications reported as a result of this event.
|
|
Search Alerts/Recalls
|