MAUDE Adverse Event Report: MIZUHO OSI COUPLER II MAIN ASSEMBLY; OPERATING TABLE, PRODUCT CODE: JEA

Model Number 5873

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 05/23/2022

Event Type  Injury  

Event Description

It was reported that a mayfield slipped during patient transfer resulting in a cut on the patient's head and the coupler ii device was somehow involved in the incident.

Event Description

It was reported that a mayfield slipped during patient transfer resulting in a cut on the patient's head and the coupler ii device was somehow involved in the incident.

Manufacturer Narrative

After investigation, it was found out that the coupler ii did not contribute to the incident and injury was related to the mayfield skull clamp (concomitant product) which is not manufactured by mizuho osi.

• Brand Name: COUPLER II MAIN ASSEMBLY
• Type of Device: OPERATING TABLE, PRODUCT CODE: JEA
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 14778107
• MDR Text Key: 294568415
• Report Number: 2921578-2022-00008
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430104534
• UDI-Public: 00842430104534
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5873
• Device Catalogue Number: 5873
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MAYFIELD SKULL CLAMP; MAYFIELD SKULL CLAMP
• Patient Outcome(s): Other