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

Catalog Number	10-401FC
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Myosure was being used gave an error message of "too much torque press pedal", pedal wouldn't operate.When pulled instrument out looked like jaw wouldn't open.Surgeon "doesn't think the patient had any harm" but the uterus was perforated.The procedure was converted to a diagnostic laparoscopy.Manufacturer response for hysteroscope (and accessories), n/a (per site reporter).

• Brand Name: N/A
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 22352630
• Report Number: 22352630
• Device Sequence Number: 18163054
• 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): 06/20/2025
• Report Date (Section F): 06/20/2025

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 Catalogue Number: 10-401FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/20/2025