MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE SUCTION VALVE (STERILE)

Model Number	MAJ-209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic approach to peripheral lesions procedure, when the guide sheath was inserted through the forceps port, an unidentified foreign object fell from the tip of the endoscope.The sheath was removed, and the foreign object was collected.Further, the suction sounded strange, but the sheath was inserted into the forceps port as it was.The sheath may have come out of the tip of the endoscope in the form of pushing out the foreign body.The physician does not think that the foreign substance came from an olympus product but wanted to have it checked out just in case.An olympus representative explained that the guide sheath was not designed to cause foreign objects to fall but the physician insisted to have it checked.The customer further explained that when using the scope in the case, the suction worsened halfway through, and the customer speculated that something in the patient's mouth may have been sucked up.Reportedly, there were no abnormalities found when cleaning the scope.The procedure was completed with the same device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.
Event or Problem Description
It was additionally reported that the device fell into the patient's lungs.The physician attempted to retrieve the device with forceps but was unable to do so.It was ultimately retrieved by suction.This created a slight delay of 12 minutes.The physician did not believe the foreign object was in the guide sheath kit.The scope had also been cleaned, so it was unlikely to have originated from the scope.The physician felt that whatever was suctioned from the patient's mouth was pushed out when the guide sheath was used.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The subject device was evaluated by olympus, and no abnormalities were observed.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it was determined that the foreign substance was iron rust and did not come from subject device (maj-209).However, the origin of the foreign substance could not be identified.This supplemental report includes a correction to d9 and h3 to provide information that was not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE SUCTION VALVE (STERILE)
• Common Device Name: SINGLE USE SUCTION VALVE
• 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: 19333393
• Report Number: 3003637092-2024-00091
• Device Sequence Number: 3102449
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: MAJ-209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 06/29/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/13/2024; 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BRONCHOVIDEOSCOPE (BF-P290/UNKNOWN SERIAL NO.); SINGLE USE GUIDE SHEATH (K-401/42K)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown