MAUDE Adverse Event Report: NOVO HEALTH SERVICES NOVO HEALTH SERVICES; GOWN, SURGICAL, L3

Model Number 514000

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2019, the end user, surgical technician/nurse, was completing their set-up for a total knee replacement procedure, when they noticed a small hole/slit in their right sleeve of a surgical gown (7403).The operating room was broken down and then reset-up for the case, while the patient was under anesthesia.This led to the patient having extending time under anesthesia, potential adverse reaction.The small hole/slit in the gown sleeve was verified by the quality manager (qm).The qm provided training with the inspection staff, informing them on possible outcomes.Procedures and policies were reviewed and no changes are noted at this time.It was reported that there was no adverse impact to the patient as a result of extended time under anesthesia and no further information has been provided.

Event Description

On (b)(6) 2019, the end user was setting up the operating room for a total knee replacement procedure.The surgical technician noticed a hole in the right sleeve, after sterile set-up was completed and the patient was under anesthesia.

• Brand Name: NOVO HEALTH SERVICES
• Type of Device: GOWN, SURGICAL, L3
• Manufacturer (Section D): NOVO HEALTH SERVICES; 4501 e. acline drive; tampa FL 33605
• Manufacturer (Section G): NOVO HEALTH SERVICES; 4501 e. acline drive; suite 1; tampa FL 33605
• Manufacturer Contact: zillery fornter ; 7086 industrial row drive; mason, OH 45040 ; 5133986406
• MDR Report Key: 8291162
• MDR Text Key: 134565756
• Report Number: 1000306225-2019-00001
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 514000
• Device Catalogue Number: 7404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other