MAUDE Adverse Event Report: STRYKER CORPORATION AHTO; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	0250070620
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Suction irrigator was leaking irrigation fluid from handle hub site, even when not in use.No identified harm to patient.

• Brand Name: AHTO
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 23424940
• Report Number: 23424940
• Device Sequence Number: 9536459
• Product Code: HET
• UDI-Device Identifier: 07613327061659
• UDI-Public: (01)07613327061659(17)270312(10)25071FG2
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/12/2025
• Report Date (Section F): 09/15/2025

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: 0250070620
• Device Catalogue Number: 250-070-620
• Device Lot Number: 25071FG2
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Date Report Sent to FDA: 09/15/2025