MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SURGICLICK; LIGHT, SURGICAL, ACCESSORIES

Catalog Number 26-012

Device Problems Contamination (1120); Split (2537)

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

Event Date 09/08/2017

Event Type  malfunction  

Event Description

As the surgeon and surgical tech placed sterile light handles covers on or lights.However both covers split and contaminated the sterile gloves worn.

• Brand Name: SURGICLICK
• Type of Device: LIGHT, SURGICAL, ACCESSORIES
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 6906656
• MDR Text Key: 87860285
• Report Number: 6906656
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2017,09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 26-012
• Device Lot Number: 44368851
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 69