MAUDE Adverse Event Report: TIDI PRODUCTS, LLC STERILE-Z; STERILE-Z PATIENT DRAPE

Model Number	5574
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based soley on customer reported issue.Attempts have been made to contact the initial reporter.
Event or Problem Description
Customer described the weight of the drape moved the frame/tracker and they also said the plastic was interfering with light causing a signal error.This is the initial report and tidi is in the process of obtaining further information and will be investigating.

• Brand Name: STERILE-Z
• Common Device Name: STERILE-Z PATIENT DRAPE
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 14241 n fenton rd; fenton MI 48430
• MDR Report Key: 7029602
• Report Number: 1825560-2017-00080
• Device Sequence Number: 1013616
• Product Code: KKX
• UDI-Device Identifier: 01618125140212
• UDI-Public: 01618125140212
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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
• Operator of Device: Other
• Device Model Number: 5574
• Device Catalogue Number: 5574
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1