MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC.; PATIENT POSITIONERS

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Date 05/07/2021

Event Type  Injury  

Event Description

It was reported a female patient, patient's height was 160.02 cm and weight was (b)(6).This patient was on the sts and they were using chest pad, large hip pads, no thigh pads and leg boards.Before the procedure the patient had a small tear near her groin.When the patient was positioned prone on the table her abdomen was almost touching the floor.When they log rolled the patient off the small tear had turned to a wound.

Event Description

It was reported a female patient, patient's height was 160.02 cm and weight was 104.326 kg.This patient was on the sts and they were using chest pad, large hip pads, no thigh pads and leg boards.Before the procedure the patient had a small tear near her groin.When the patient was positioned prone on the table her abdomen was almost touching the floor.When they log rolled the patient off the small tear had turned to a wound.

Manufacturer Narrative

Based on the details provided, it appears that there was already a small tear near the patient's groin, that may not have been managed prior to positioning for surgery.The patient's weight coupled with prone positioning and lack of thigh pads likely exacerbated the injury during the procedure.Based on information received to-date, it does not appear that the table or its components when properly caused the issue reported.No further details were provided by the hospital so we have only the initial report on which to base this assessment.

• Type of Device: PATIENT POSITIONERS
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 11808319
• MDR Text Key: 260679630
• Report Number: 2921578-2021-00015
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 104