BOSTON SCIENTIFIC CORPORATION EXALT CONTROLLER; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
|
Back to Search Results |
|
Model Number M00542430 |
Device Problems
Device Sensing Problem (2917); Optical Problem (3001); Unexpected Shutdown (4019)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/14/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: the reported healthcare facility is: (b)(6) hospital.(b)(6).Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.
|
|
Event Description
|
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-07080 for the exalt model d scope.It was reported to boston scientific corporation that an exalt model d scope and exalt model d controller were during an endoscopic retrograde cholangiopancreatography (ercp) used to treat choledocholithiasis performed on (b)(6) 2023.About 20 to 30 minutes into the procedure, the scope's image went dark, then bright, and then returned to normal.A balloon was inserted into the scope in preparation for lithotripsy of the stone.About two minutes into dilation, the screen went black resulting in a loss of visualization.The exalt controller then unexpectedly shut down.The scope was unplugged and the controller was rebooted multiple times but the scope would not turn back on.The accessories and scope were then removed under fluoroscopy and the procedure was successfully completed using a reusable scope.There were no patient complications reported as a result of this event.
|
|
Manufacturer Narrative
|
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: the reported healthcare facility is: (b)(6).Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h11: additional information was received stating that the exalt model d controller has been tested since the event and is functioning as intended.As there is no reportable allegation against the exalt model d controller itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.
|
|
Event Description
|
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-07080 for the exalt model d scope.It was reported to boston scientific corporation that an exalt model d scope and exalt model d controller were during an endoscopic retrograde cholangiopancreatography (ercp) used to treat choledocholithiasis performed on (b)(6) 2023.About 20 to 30 minutes into the procedure, the scope's image went dark, then bright, and then returned to normal.A balloon was inserted into the scope in preparation for lithotripsy of the stone.About two minutes into dilation, the screen went black resulting in a loss of visualization.The exalt controller then unexpectedly shut down.The scope was unplugged and the controller was rebooted multiple times but the scope would not turn back on.The accessories and scope were then removed under fluoroscopy and the procedure was successfully completed using a reusable scope.There were no patient complications reported as a result of this event.Additional information received on january 4, 2024 - the exalt model d controller has been tested since the event and is functioning as intended.
|
|
Search Alerts/Recalls
|
|
|