MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS MYOSURE LITE TISSUE REMOVAL DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Faculty surgeon while using reprocessed myosure lite tissue removal device, informed circulation nurse that device was not working.

• Brand Name: MYOSURE LITE TISSUE REMOVAL DEVICE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 14842701
• Report Number: 14842701
• Device Sequence Number: 4640286
• Product Code: HIH
• UDI-Device Identifier: 07613327507119
• UDI-Public: (01)07613327507119(17)250125(10)13527924
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/14/2022
• Report Date (Section F): 06/14/2022

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: N/A
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 13527924
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White
• Date Report Sent to FDA: 06/14/2022