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

Model Number GAR004

Device Problem Break (1069)

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

Event Date 08/17/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 208991507
• Report Number: 3014749926-2020-00001
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 04897106950225
• UDI-Public: 04897106950225
• Combination Product (y/n): N
• PMA/PMN Number: K181509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2020
• Device Model Number: GAR004
• Device Lot Number: 20022682, 20022627, 20021025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other