MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS N/A; LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The closesure procedure kit handle broke outside the patient intraoperatively.This device was removed and a new kit was used.No apparent harm to patient.

• Brand Name: N/A
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr; tempe AZ 85283
• MDR Report Key: 25811640
• Report Number: 25811640
• Device Sequence Number: 17633345
• Product Code: NLM
• UDI-Device Identifier: 00885825013318
• UDI-Public: (01)00885825013318(17)290310(10)0001357656
• 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): 07/07/2026
• Report Date (Section F): 07/07/2026

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: CTI-512N
• Device Lot Number: 0001357656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2026
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 126 KG
• Date Report Sent to FDA: 07/07/2026