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

Model Number GAR004C

Device Problem Break (1069)

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

Event Date 09/09/2020

Event Type  malfunction  

Event 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
• Type of Device: 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
• Manufacturer (Section G): GA HEALTH COMPANY LIMITED; unit 18, 21/f, metropole squar; 2 on yiu street, shatin, n.t.; hong kong, ; HK
• Manufacturer Contact: cindy ye ; unit 18, 21/f, metropole squar; 2 on yiu street, shatin, n.t.; hong kong, ; HK
• MDR Report Key: 10802110
• MDR Text Key: 239838490
• Report Number: 3014749926-2020-00002
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 04897106950232
• UDI-Public: 04897106950232
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K181509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/25/2023
• Device Model Number: GAR004C
• Device Lot Number: 19122008, 20031803
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1