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

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When pressing the pedal to stop initiating the device, the device had a 3.5 second delay in stopping.

• 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: 25299701
• Report Number: 25299701
• Device Sequence Number: 15779666
• Product Code: HIH
• UDI-Device Identifier: 37613327507110
• UDI-Public: (01)37613327507110(17)271123(10)16433969
• 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): 05/18/2026
• Report Date (Section F): 05/18/2026

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: 16433969
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Date Report Sent to FDA: 05/18/2026