MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/15/2024

Event Type  Injury  

Event Description

It was reported during an endoscopic ultrasound (eus) and endoscopic retrograde cholangiopancreatography (ercp) procedure the single use distal cover fell off the duodenovideoscope.It was noticed after the procedure was completed and the duodenovideoscope was removed from the patient.The endoscopist then performed an esophagogastroduodenoscopy (egd) to locate the distal cover.They were unable to find the distal cover visible in the gastrointestinal (gi) tract, esophagus, stomach, or duodenum.A decision was made to perform an unplanned bronchoscopy to ensure the distal cover did not become dislodged and fall into the respiratory tract.An abdominal x-ray was done post-procedure and the cap was located in the intestines.It was thought the patient would pass the distal cover in a bowel movement.Due to the reported event and subsequent procedures, the patient's anesthesia was extended about 30 minutes.There was no reported patient harm.

Manufacturer Narrative

This report is related to the following linked patient identifier: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-00212.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, it was determined that the distal cover was likely not properly attached to the scope and easily detached due to a load during the procedure.Since it is difficult to visually detect the attachment of this device, it is possible that the description in the previous instructions for use (ifu) manual was insufficient.However, the root cause could not be identified.Furthermore, olympus has revised the ifu to add detailed inspection and attachment instructions for the distal cover.The event can be detected/prevented by following the ifu which state: (ifu at time of occurrence) ¿section 8.2- inspection of the distal cover: should any irregularity be observed when inspecting the distal cover, do not use it.A distal cover with irregularity could not serve the endoscope properly and/or could fall off during the examination.Using the endoscope without the distal cover could cause patient injury.Confirm that the distal cover is free from any irregularities such as cracks, chips, pinholes, or deformation.¿ (ifu at time of occurrence) ¿section 9.3 - attaching the distal cover: never use a distal cover with cracks or pinholes.Replace it with a new one.If a distal cover with cracks or pinholes is used, it could fall off during the examination and/or, it may cause thermal injury due to electric current leaks from cracks or pinholes when high-frequency cauterization treatment is performed.Also, using the distal cover with cracks may cause patient injury due to sharp edges.Do not apply anti-fogging products, olive oil, or products containing petroleum-based substances (e.G., vaseline®) to the distal cover or the endoscope.These products may cause cracks in the distal cover.If a distal cover with cracks is used, it may cause patient injury such as: thermal injury from electric current leaks when performing high-frequency cauterization treatment.Gently hold the distal part of the bending section and the distal cover.Align the opening side of the distal cover with the lens side of the distal end of the endoscope.Put your finger onto the center on the top of the distal cover and push the top of the distal cover straight onto the distal end of the endoscope until the hook of the distal ring is completely visible within the opening of the distal cover.Hold the distal part of the bending section.Pull the distal cover gently to confirm that the distal cover on the distal end of the endoscope does not slip and come off.Twist the distal cover gently in both directions and confirm that the distal cover on the distal end of the endoscope does not slip and come off.Confirm that the distal cover is free of cracks or deformation.¿ (current/ revised ifu) ¿section 9.3 and section 9.4¿.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Also, information has been added to h4, h7, and h9.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplement report is being submitted to include the voluntary report number from the customer.The customer submitted this event in report number (b)(4) through the fda's medsun program.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19007404
• MDR Text Key: 338981859
• Report Number: 3003637092-2024-00048
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170441271
• UDI-Public: 04953170441271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H3608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 05/27/2024; 09/12/2024
• Supplement Dates FDA Received: 05/30/2024; 09/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1071-2024
• Patient Sequence Number: 1
• Treatment: TJF-Q190V.
• Patient Outcome(s): Required Intervention
• Patient Sex: Unknown