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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE DISTAL COVER; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE DISTAL COVER; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM Back to Search Results
Model Number MAJ-2315
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2023
Event Type  malfunction  
Event Description
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.
 
Event Description
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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Brand Name
SINGLE USE DISTAL COVER
Type of Device
ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
800 west park drive
westborough MA 01581
MDR Report Key16852571
MDR Text Key314366724
Report Number16852571
Device Sequence Number1
Product Code NWB
UDI-Device Identifier04953170403019
UDI-Public04953170403019
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMAJ-2315
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/28/2023
Event Location Hospital
Date Report to Manufacturer05/02/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/02/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/04/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age19345 DA
Patient SexFemale
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