BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
|
Back to Search Results |
|
Model Number M00545170 |
Device Problems
Break (1069); Use of Device Problem (1670)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/13/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported to boston scientific corporation that an autotome rx 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire of the autotome rx 44 broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: the complainant reported that the device was energized prior to bowing; however, according to the instructions for use (ifu), "precaution: the sphincterotome does not need to be energized prior to performing sphincterotomy.Energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity." additionally, it was also indicated that the device was energized when not in contact with tissue; however, the ifu states "precaution: it is recommended to maintain direct and constant contact with tissue when applying electrocautery current.Failure to do so may result in broken cut wire, damage to the endoscope and/or patient injury.".
|
|
Manufacturer Narrative
|
Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was broken and bent at 5mm from the proximal pierced hole, which are consistent with the findings when the device was observed under magnification.Additionally, the ends of the broken cutting wire were blackened.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken, bent and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the wire being broken could have been generated due to not maintaining a direct and constant contact with tissue when applying electrocautery current.Once the cutting wire breaks, any attempt to remove the device from the scope can lead to hit the working channel of the scope with the broken section, consequently, bending the cutting wire.Based on the information that the device was energized prior to bowing; however, the instructions for use (ifu) indicates, "precaution: the sphincterotome does not need to be energized prior to performing sphincterotomy.Energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity." additionally, the device was energized when not in contact with tissue; however, according to the instructions for use (ifu), "precaution: it is recommended to maintain direct and constant contact with tissue when applying electrocautery current.Failure to do so may result in broken cut wire, damage to the endoscope and/or patient injury." therefore, the most probable root cause for the reported problem of wire break will be documented as failure to follow instructions due to problems traced to the user not following the manufacturer's instructions.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu).
|
|
Event Description
|
It was reported to boston scientific corporation that an autotome rx 44 was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire of the autotome rx 44 broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: the complainant reported that the device was energized prior to bowing; however, according to the instructions for use (ifu), "precaution: the sphincterotome does not need to be energized prior to performing sphincterotomy.Energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity." additionally, it was also indicated that the device was energized when not in contact with tissue; however, the ifu states "precaution: it is recommended to maintain direct and constant contact with tissue when applying electrocautery current.Failure to do so may result in broken cut wire, damage to the endoscope and/or patient injury.".
|
|
Search Alerts/Recalls
|
|
|