MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Myosure reach error "excessive torque detected, reduce pressure on device, tap foot pedal to continue - (b)(4)." device would not release from machine.Needed to obtain new machine and handpiece.

• Brand Name: N/A
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr; tempe AZ 85283
• MDR Report Key: 22849167
• Report Number: 22849167
• Device Sequence Number: 4461869
• Product Code: HIH
• UDI-Device Identifier: 07613327507133
• UDI-Public: (01)07613327507133
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/18/2025
• Report Date (Section F): 08/18/2025

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: 10-401FC
• Device Lot Number: 25B13RA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• 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
• Date Report Sent to FDA: 08/18/2025