MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. WILSON PLUS RADIOLUCENT FRAME UNIVERSAL; SURGICAL OPERATING TABLE

Model Number 5319G

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Pressure Sores (2326)

Event Date 05/22/2020

Event Type  Injury  

Event Description

Patient was positioned on mizuho black wilson frame for spine procedure.Procedure lasted 3 hours 13 minutes.After procedure patient flipped back supine.Red, blistered areas noted down both sides of patient where the patient was resting on the foam pads.Pads had been replaced on the frame around six months ago.Frame has been used many times since then.Disposable sheet from our custom turnover kit was used to cover the frame.Silvadene cream used to treat patient wounds.Patient discharged and will receive treatment in outpatient wound center.

Manufacturer Narrative

A disposable sheet from a turnover kit was placed on the frame between the patient and the pads.The pads did not show wear and have been in use for several months.The patient was not obese, nor was the case long.The use of extra material between the patient and the pads combined with the patient noted perspiration likely contributed to the pressure issues reported.The customer indicated that since reporting this issue, they have continued to use the frame with no further incidents.

Event Description

Patient was positioned on mizuho black wilson frame for spine procedure.Procedure lasted 3 hours 13 minutes.After procedure patient flipped back supine.Red, blistered areas noted down both sides of patient where the patient was resting on the foam pads.Pads had been replaced on the frame around six months ago.Frame has been used many times since then.Disposable sheet from our custom turnover kit was used to cover the frame.Sivadene cream used to treat patient wounds.Patient discharged and will receive treatment in outpatient wound center.

• Brand Name: WILSON PLUS RADIOLUCENT FRAME UNIVERSAL
• Type of Device: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca
• MDR Report Key: 10135704
• MDR Text Key: 194556117
• Report Number: 2921578-2020-00018
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430110238
• UDI-Public: 00842430110238
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5319G
• Device Catalogue Number: 5319G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 96