MAUDE Adverse Event Report: STRYKER-ENDOSCOPY TIJUANA MX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number	CTI-512N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported during the procedure the device snapped on the plastic part of the instrument, but nothing broke off in the patient.Multiple attempts were made to obtain additional information.No information was provided regarding patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER-ENDOSCOPY TIJUANA MX; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana 22643 ; MX 22643
• Manufacturer (Section G): STRYKER-ENDOSCOPY TIJUANA MX; ave todos los santos no. 10802; col. leandro valle, baja ca; tijuana 22643 ; MX 22643
• Manufacturer Contact: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 24866254
• Report Number: 3020163307-2026-00005
• Device Sequence Number: 13391246
• Product Code: NLM
• UDI-Device Identifier: 00885825013318
• UDI-Public: 00885825013318
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: CTI-512N
• Device Catalogue Number: CTI-512N
• Device Lot Number: 0001266949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown