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

Model Number 0375940200

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2020

Event Type  malfunction  

Event 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
• Type of Device: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical ct; san jose CA 95138
• MDR Report Key: 9888151
• MDR Text Key: 185223692
• Report Number: 9888151
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07613327054736
• UDI-Public: (01)07613327054736(17)231003(10)18277CE2
• 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: 03/26/2020,03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0375940200
• Device Catalogue Number: 0375-940-200
• Device Lot Number: 18277CE2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1