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

Model Number STERILE LIGHTHANDLE COVER

Device Problems Unsealed Device Packaging (1444); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

Event Type  malfunction  

Event Description

Pre-packaged and pre-sterilized steris lighthandle cover within a surgical supply pack was opened (lid peeled off) and 1 or 2 hairs were noted around and under lighthandle cover within its packaging.Packaging and lighthandle cover with hair passed off sterile field and discarded, gloves changed; no patient harm.Packaging, lighthandle cover and hair not saved.

• 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: 9943255
• MDR Text Key: 187040276
• Report Number: 9943255
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STERILE LIGHTHANDLE COVER
• Device Catalogue Number: LB53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1