MAUDE Adverse Event Report: STERIS CORPORATION; LIGHT, SURGICAL, ACCESSORIES

Model Number STERILE LIGHTHANDLE COVER

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 07/07/2019

Event Type  malfunction  

Event Description

The sterile surgical pack was opened.The light handle was picked up by the scrub tech.The cover on the packaging was peeled back when the hair was discovered inside the light handle package.The light handle with packaging and hair was immediately passed off and the scrub changed her gloves.No contamination of the sterile field.

• Brand Name: NA
• Type of Device: LIGHT, SURGICAL, ACCESSORIES
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 8850603
• MDR Text Key: 152943412
• Report Number: 8850603
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2019

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: Other
• Device Model Number: STERILE LIGHTHANDLE COVER
• Device Catalogue Number: LB53
• Device Lot Number: 7168
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14600 DA