MAUDE Adverse Event Report: Mizuho Orthopedic Systems, Inc. PILLOW, GENTLETOUCH, 5 INCH RT; Surgical Patient Positioner

Model Number	1937S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gentletouch pillow didn't expand all the way.Patient's face was reported to be the touching the table.
Additional Manufacturer Narrative
Per the information obtained from the investigation, no patient injury/harm was reported.Upon review of the instructions for use (ifu), it was found to be sufficient with appropriate warnings pertaining to the usage of the pillow.An unexpanded pillow was used to position the patient's face despite being not being recommended in the ifu.The root cause of this incident is thus deemed as a use error as there was a failure to operate the device according to manufacturer's recommendations or recognized best practices for patient safety.

• Brand Name: PILLOW, GENTLETOUCH, 5 INCH RT
• Common Device Name: Surgical Patient Positioner
• Manufacturer (Section D): Mizuho Orthopedic Systems, Inc.; 30031 ahern ave; union city CA 94587 -123
• Manufacturer (Section G): Mizuho Orthopedic Systems, Inc.; 30031 ahern ave; union city CA 94587 -123
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587--123 ; +1(510)429-1500
• MDR Report Key: 50063438
• Report Number: 2921578-2026-00020
• Device Sequence Number: 18427512
• Product Code: CCX
• UDI-Device Identifier: 00842430110115
• UDI-Public: (01)00842430110115(10)MIZ260505(11)260505
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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 Model Number: 1937S
• Device Catalogue Number: 1937S
• Device Lot Number: DEL260505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown