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

Model Number	MAJ-2315
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the distal cap of the duodenovideoscope fell off during an unspecified procedure.There were no reports of a procedure delay, and there were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: g1, h2, h6, h11.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The event can be detected/prevented by following the instructions for use which state: 9.3 inspection of the distal cover warning: 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 and this could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.In addition, if the distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed.Confirm that the distal cover is free from any irregularities such as cracks, chips, pinholes, or deformation.If the distal cover shows any irregularity, use a spare instead.9.4 attaching the distal cover [warning].Never use the endoscope unless the distal cover is properly attached to the distal end.If the distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.Also, continuing the examination with the distal cover off may cause patient injury by the uncovered distal end of the endoscope.In addition, if the distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed.When the endoscope is repeatedly inserted into the body cavity, always confirm that the distal cover is attached properly before insertion.If the distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.Also, continuing the examination with the distal cover off may cause patient injury by the uncovered distal end of the endoscope.In addition, if the distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed.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.Detach the distal cover from the distal end of the endoscope when the distal cover cannot be attached to the endoscope smoothly or any incorrect attaching procedure is noticed.Refer to section 9.5, ¿detach the distal cover¿ for detaching the distal cover.With a new distal cover, repeat step 1 through 4.If the distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.Also, continuing the examination with the distal cover off may cause patient injury by the uncovered distal end of the endoscope.In addition, if the distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed.[caution].Do not apply anti-fogging products, non-water soluble lubricant (e.G., silicone spray, silicone oil), cooking oil (e.G., 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: when attaching the distal cover, gently hold the bending section as close to the distal end as possible.Forcefully grasping other parts of the bending section can damage the mechanism of the bending section or deform its covering.It may also become impossible to straighten the bending section during an examination.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: SINGLE USE DISTAL COVER
• Common Device Name: 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 190-0 182; JA 190-0182
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21546598
• Report Number: 3003637092-2025-00037
• Device Sequence Number: 6987913
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K220587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown