MAUDE Adverse Event Report: MIZUHO OSI RATCHET TOWER; MOUNTING BRACKET

Model Number 7803-579

Device Problem Device Slipped (1584)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

Table lowered on its own during surgery.

Manufacturer Narrative

The suspect medical device returned to the manufacturer was received in a disassembled fashion.This made it unable to conduct proper device evaluation to identify the root cause of the incident.An in-service training is requested to educate the customer on preventative maintenance and repair procedures.

Event Description

Table lowered on its own during surgery.

• Brand Name: RATCHET TOWER
• Type of Device: MOUNTING BRACKET
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 16507775
• MDR Text Key: 310990721
• Report Number: 2921578-2023-00002
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430104220
• UDI-Public: 00842430104220
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7803-579
• Device Catalogue Number: 7803-579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1