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

Model Number	306026-0000-000
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Hair was found in the package before it was opened in the operating room.It was found in the opmi drapes sterile package manufactured by carl zeiss (b)(4).There was no patient involvement.

• 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: 8145988
• Report Number: 8145988
• Device Sequence Number: 1407380
• Product Code: KKX
• UDI-Device Identifier: 04049539101198
• UDI-Public: (01)04049539101198(10)D180092A(17)230128(241)3060260000000
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/05/2018
• Report Date (Section F): 12/05/2018

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: Other
• Device Model Number: 306026-0000-000
• Device Catalogue Number: 306026-0000-000
• Device Lot Number: D180092A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2018
• 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: 12/05/2018