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

Model Number MAJ-2315

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

An olympus sales representative reported on behalf of the customer that they found a large piece of tissue in the inside corner of the single use distal cover maj-2315.The issue was found during after a therapeutic stone removal procedure.The scope was inspected prior to use.No medical interventions or impact on the patient were reported.Related patient identifier: (b)(6).

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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 over 1 year since the subject device was manufactured.Based on the results of the investigation, (per capa no.Omsc-hq-153-19) the cause of the mucosal damage was likely caused by the following user operations: 1.The scope was removed while using the suction function.2.The scope was removed immediately after suction.The event can be detected/prevented by following the instructions for use (ifu) which state: warning: (4.4 tjf scope manual) ¿take caution applying suction when the distal end is in contact with the mucosal surface.The suction can cause the distal end to aspirate the mucosal membrane.Moving or withdrawing the endoscope under this condition may cause patient injury and/or bleeding.This can be more common while degassing in the stomach, suctioning debris, and operating in a narrow lumen (e.G., esophagus, duodenum).To prevent patient injury and bleeding, make sure to: 1.Only apply suction when the endoscope is stationary.2.After releasing the suction valve, check the endoscopic image to confirm that the mucosal membrane is not aspirated before moving the endoscope.Releasing the suction valve might not immediately release the mucosal membrane if it becomes aspirated.¿ this supplemental report includes a correction to d4 and d8 from the initial medwatch.Also, additional information has been added to h4.Olympus will continue to monitor field performance for this device.

• 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: 18171880
• MDR Text Key: 328971215
• Report Number: 3003637092-2023-00241
• 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
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H2916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1