MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SUCTION VALVE

Model Number MAJ-207

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 10/26/2023

Event Type  malfunction  

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.

Event Description

The customer reported to olympus the suction valve dislodged causing the irrigation fluid to not reach the intended irrigation site.The suction valve had been reused many times and deteriorated, was not very stable after connecting the scope, and easily fell to the ground by gravity after hanging the bag.The issue occurred during a diagnostic bronchoscopy that was completed with a similar device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and customer feedback.Please see updates to b5 of the initial medwatch.The device history record was unable to be reviewed for this device since the serial 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, olympus tried to replicate the reported failure using a sample in a unspecified lot of the same product and the labeling review and confirmed that improper fitting of the valve into the scope resulted in came off of the suction valve.Alternatively, it is possible that the fitting part with the scope was worn out through repeated use, making it easier to come off, as the customer mentioned that it had deteriorated and became easier to come off.However, the exact cause could not be determined because the actual item had not been returned.However, the root cause of the reported event is unable to be determined.The event can be detected by following the instructions for use (ifu) section which state: 6.1 attachment of suction valve (fig.1 and fig.2) firmly attach the suction valve to the suction cylinder of the endoscope.If the suction valve is attached to the endoscope improperly with a gap between the base of the suction valve and the top of the suction cylinder, the suction valve may detach from the endoscope and/or may cause patient debris to leak or spray from the gap, posing an infection-control risk.1.Place the suction valve into the suction cylinder aligning the arm of the main body with the white index mark on the endoscope.Push down on the suction valve button with your finger until it clicks into place.2.Inspect and verify that the base of the valve is in contact with the suction cylinder properly.Improper attachment, where a gap still exists between the base of the suction valve and the top of the suction cylinder.Olympus will continue to monitor field performance for this device.

Event Description

The customer confirmed event occurred during the procedure.The device was switched out for a new suction valve maj-207 lot number unknown.There were no procedural delays.It is unknown if the patient had any pre-existing conditions at the time of the event.It is unknown if the device inspected prior to usage.It is unknown if the procedure was therapeutic or diagnostic, and the patient¿s condition is unknown.There was no prolonged hospital stay and the patient was discharged as planned.No further information can be provided.

• Brand Name: SUCTION VALVE
• Type of Device: 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: 18141943
• MDR Text Key: 328188325
• Report Number: 3003637092-2023-00239
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170063428
• UDI-Public: 04953170063428
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

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
• Device Operator: Health Professional
• Device Model Number: MAJ-207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BF-1T260 ( (B)(6) ).