OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE DISTAL COVER; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
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Model Number MAJ-2315 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2023 |
Event Type
malfunction
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Event Description
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During an endoscopic retrograde cholangiopancreatography (ercp), the duodenoscope requires an olympus distal cover (using the resigned maj-2315 cover) to be attached to cover the distal end of the insertion tube and around the forceps elevator.This was put on at the beginning of the case per usual.We finished the case, got the patient extubated and flipped back supine onto the cart.We did the debrief timeout at the end and the distal ercp cover was not on the end of the scope.We asked the doctor to make sure he did not remove the cover, we found it in the patient's mouth.We were able to get it out without any issues.This is the second time recently that a distal cover detachment has happened to the team member who reported this event.This team member states that the covers are being put on right (following the manufacturer's instructions for use) at the beginning of the procedure.The team is using the covers correctly, but on removal from the patient, it bumps past the bite block in the patient's mouth, causing the cover to pop off.We even had added a new step in our process to check the tip of the scope immediately after removal from the patient because this is such a concern for us.We have been using the second generation distal cover.When checking our inventory, we had lot# h2624 x 40 ea and lot # h2714 x 16 each.We had located only one of the recalled lot (maj 2315 lot # h2126), which was pulled from use and destroyed.Our endoscopy account manager has been apprised of this event/concern that the covers are dislodging.They asked to schedule an inservice to ensure that the distal cover is being placed correctly on the scope.They also sent the user guide for reference.
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Event Description
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During an endoscopic retrograde cholangiopancreatography (ercp), the duodenoscope requires an olympus distal cover (using the redesigned maj-2315 cover) to be attached to cover the distal end of the insertion tube and around the forceps elevator.This was put on at the beginning of the case per usual.We finished the case, got the patient extubated and flipped back supine onto the cart.We did the debrief timeout at the end and the distal ercp cover was not on the end of the scope.We asked the doctor to make sure he did not remove the cover, we found it in the patient's mouth.We were able to get it out without any issues.This is the second time recently that a distal cover detachment has happened to the team member who reported this event.This team member states that the covers are being put on right (following the manufacturer's instructions for use) at the beginning of the procedure.The team is using the covers correctly, but on removal from the patient, it bumps past the bite block in the patient's mouth, causing the cover to pop off.We even had added a new step in our process to check the tip of the scope immediately after removal from the patient because this is such a concern for us.We have been using the second generation distal cover.When checking our inventory, we had lot# h2624 x 40 ea and lot # h2714 x 16 each.We had located only one of the recalled lot (maj 2315 lot # h2126), which was pulled from use and destroyed.Our endoscopy account manager has been apprised of this event/concern that the covers are dislodging.They asked to schedule an inservice to ensure that the distal cover is being placed correctly on the scope.They also sent the user guide for reference.
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