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	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the closesure procedure kit handle broke outside the patient intraoperatively.There was no patient injury reported, and no information was provided regarding medical intervention or extended procedure time.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.The submitted medsun form stated that the device was not available for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.As the complaint device was not returned, a conclusive root cause could not be determined, and the reported event could not be confirmed.A review of the dhr for the reported lot/serial number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: excessive force.Contact of needle point with hard object.Shipping/handling damage or extreme conditions.Attempting to bend or otherwise alter the shape of the device/shaft.The instructions for use (ifu) state: "before beginning the procedure, verify overall compatibility of all instruments and accessories." "inspect the instrument for overall condition and physical integrity.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery." the reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

• 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 ; +1(888)888-3433
• MDR Report Key: 50214137
• Report Number: 3020163307-2026-00009
• Device Sequence Number: 6110819
• 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
• Report Date (Section B): 08/11/2026

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: 0001357656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2026
• 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 Age: 45 YR
• Patient Sex: Female
• Patient Weight: 277 LB
• Patient Race: Black Or African American