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

Catalog Number	CB12LT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of trocar broke off inside of patient.These trocar sleeves are reprocessed by stryker sustainability solutions.It is unknown how many times this device was reprocessed.

• 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: 24144307
• Report Number: 24144307
• Device Sequence Number: 18357788
• Product Code: NLM
• UDI-Device Identifier: 00885825014438
• UDI-Public: (01)00885825014438(17)271105(10)16376102
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/08/2026
• Report Date (Section F): 01/08/2026

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
• Device Catalogue Number: CB12LT
• Device Lot Number: 16376102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2026
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Date Report Sent to FDA: 01/08/2026