MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG OPMI DRAPES STERILE; DRAPE, SURGICAL

Model Number	306070-0000-000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During case set up a bug was discovered in the microscope drape.The whole field was contaminated and broken down.Case was not started.Drape and packaging saved to give to quality.Pictures attached.Drape and packaging saved.

• Brand Name: OPMI DRAPES STERILE
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): CARL ZEISS MEDITEC AG; 5160 hacienda drive; dublin CA 94568
• MDR Report Key: 12286924
• Report Number: 12286924
• Device Sequence Number: 14412716
• Product Code: KKX
• UDI-Device Identifier: 04049539101204
• UDI-Public: (01)04049539101204(10)D192562(17)240928(241)3060700000000
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2021
• Report Date (Section F): 07/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: 306070-0000-000
• Device Lot Number: D192562
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/22/2021