MAUDE Adverse Event Report: STRYKER ENDOSCOPY FORMULA; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number	0375940200
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Discovered what appears to be a hair within the seal of the packaging - part of contaminant inside packaging with device and part of contaminant outside the packaging.Package not opened; no patient exposure.

• Brand Name: FORMULA
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct; san jose CA 95138
• MDR Report Key: 9888151
• Report Number: 9888151
• Device Sequence Number: 2248190
• Product Code: GFA
• UDI-Device Identifier: 07613327054736
• UDI-Public: (01)07613327054736(17)231003(10)18277CE2
• 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): 03/25/2020
• Report Date (Section F): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0375940200
• Device Catalogue Number: 0375-940-200
• Device Lot Number: 18277CE2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2020
• 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: 03/26/2020