MAUDE Adverse Event Report: GA HEALTH COMPANY LIMITED DISPOSABLE ENDOSCOPE VALVES SET; SUCTION VALVE

Model Number	GAR004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The suction button is reported sticky and/or broken during or after the procedure from three lots.The events occurred outside the us and the device is not returned for analysis.There is no patient injury reported.
Additional Manufacturer Narrative
No patient injury or safety issue reported.The disassembly of suction valve may cause prolonged procedure.It is determined that such impact will not be a major issue in procedure and therefore immediate corrective action for on field product is not required.Analysis has estimated the probability of device failure to be low.On 2020-11-03 ga health company limited (hereinafter referred to as "ga health") began voluntarily recalling suction valve which is also included in disposable endoscope valves set from our customers and hospitals.
Event or Problem Description
The suction button is reported sticky and/or broken during or after the procedure from three lots.The events occurred outside the us and the device is not returned for analysis.There is no patient injury reported.

• Brand Name: DISPOSABLE ENDOSCOPE VALVES SET
• Common Device Name: SUCTION VALVE
• Manufacturer (Section D): GA HEALTH COMPANY LIMITED; unit 18,21/f, metropole square; 2 on yiu street ,shatin, n.t.; HK
• MDR Report Key: 10586521
• Report Number: 3014749926-2020-00001
• Device Sequence Number: 1151516
• Product Code: OCX
• UDI-Device Identifier: 04897106950225
• UDI-Public: 04897106950225
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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 Expiration Date: 06/03/2020
• Device Model Number: GAR004
• Device Lot Number: 20022682, 20022627, 20021025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other