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

Model Number MAJ-207

Device Problems Product Quality Problem (1506); Defective Device (2588)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated at sbc olympus (b)(4).The device evaluation noted the following findings: 18 suction valves in total were received in two bags of physical packaging, and the analysis results are as follows: 1.The appearance of the suction valves is normal, it is easy to loosen after being installed on the endoscope, and the spare valves of the same model are normal.2.Measure the outer diameter of the suction valves, which is less than the spare valves of the same model.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, at delivery acceptance, it was found the suction buttons were loose when installed on the scope and easy to fall off.There is no patient involvement associated on this reported event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction: g2.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it was concluded/assumed that the reported suction valves were within standard, but loosening torque was close to the tolerance limit due to variability in molding.In conclusion, a root cause could not be identified for this reported phenomenon.Olympus will continue to monitor field performance for this device.

• Brand Name: SUCTION VALVE
• Type of Device: SUCTION VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13066987
• MDR Text Key: 284698416
• Report Number: 8010047-2021-16687
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-207
• Device Lot Number: H9Y12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• 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-260