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

Model Number	GAR004C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Suction valve reported fell apart and did not work from 2 lots.The events occurred outside the us.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 squar; 2 on yiu street, shatin, n.t.; hong kong, ; HK
• MDR Report Key: 10802110
• Report Number: 3014749926-2020-00002
• Device Sequence Number: 3949509
• Product Code: OCX
• UDI-Device Identifier: 04897106950232
• UDI-Public: 04897106950232
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Report Date (Section B): 11/05/2020

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: No Information
• Device Expiration Date: 03/25/2023
• Device Model Number: GAR004C
• Device Lot Number: 19122008, 20031803
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial 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