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

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.

• 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 Key: 16852571
• MDR Text Key: 314366724
• Report Number: 16852571
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Female