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

Model Number	MAJ-209
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned for evaluation.No findings available.The cause could not be determined.No further information was reported.However, it was found that the lot number of the suction valve being used was of an older model.The customer ordered the new model of the suction valve which was found functional.The most likely cause is due to an unintended user error.Customer confirmed the suction valve will not be returned and the issue has been resolved.
Event or Problem Description
The customer reported to olympus that during a bronchoscopy procedure the suction valve was found loose and was popping out of the device¿s port.The intended procedure was able to be completed with the same suction valve.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information and device manufacturer date.The legal manufacturer reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.The lm reviewed the manufacturing record for the device with lot number h8z04, and no abnormality or irregularity was found.The actual device was not returned for this complaint.We've tested our own suction valve (manufactured after supplier change) and confirmed that more force was required to attach to an endoscope.The lm reported that the most probable causes for the reported event are as follows: in august 2018, the mold supplier of the gray suction pipe was changed, and the manufacturing method was also changed.This change probably caused minor but negative effect on the maj-209, although it was verified to meet the specification.Compared to the previous version, the new one requires more force to attach to the endoscope, also to detach.Besides, the suction pipe easily breaks off when user applies force to pull(push) it up.

• Brand Name: SINGLE USE SUCTION VALVE (STERILE)
• Common Device Name: SINGLE USE SUCTION VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10011485
• Report Number: 8010047-2020-02415
• Device Sequence Number: 19529304
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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-209
• Device Lot Number: H8ZO4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 92