MAUDE Adverse Event Report: STRYKER-ENDOSCOPY PHOENIX USA; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	201101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported catheter bending mechanism is not functioning properly and does not operate as intended.There was no patient injury or medical intervention and the extended procedure time reported was a few minutes.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.The complaint device was received in its secondary packaging with no restraints to properly secure it in place during shipping and handling.Upon visual inspection of the received complaint device, no relevant visible damage was detected.The catheter shaft, handle, steering mechanism, connector pins, and electrodes appeared to be intact.During functional inspection, the catheter deflected smoothly when the steering mechanism was actuated, indicating proper mechanical function.However, during deflection the distal tip appeared to be distorted when the catheter was fully deflected.Additionally, the device was evaluated and the device did not meet the planarity specification.The device inspection indicated that the "does not operate as intended¿ portion of the reported event was confirmed, as the curve of the device after deflection did not meet specification.The ¿bending mechanism is not functioning properly¿ portion was not confirmed, as the device demonstrated proper mechanical function of the handle.Since the device was return to stryker without the proper restraint to secure it in place during shipping, the extent of the issue experienced by the customer could not be fully determined, as shipping damage may have affected the condition of the returned device.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the likely root cause is a curve issue as a result of mishandling subsequent to distribution, including shipping and storage conditions or improper manipulation of the device.The instructions for use (ifu) state: - ep catheters should be used only by or under the supervision of an appropriately trained physician using proper procedures and techniques.- do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use.- do not alter this device.- inspect the packaging and catheter for damage or defects prior to use.- avoid excessive torque, stretching, kinking and/or bending of catheter, as this may interfere with distal tip shaping or cause damage to internal electrode wires.- avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters.Handle catheter with care to avoid improper electrical functioning.- do not insert or withdraw the catheter without straightening the catheter tip.- use fluoroscopic guidance during catheter positioning.- prior to use, store reprocessed ep catheters in a cool, dry, dark place.The reported event will continue to be monitored through post-market surveillance.

• Brand Name: NA
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STRYKER-ENDOSCOPY PHOENIX USA; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer (Section G): STRYKER-ENDOSCOPY PHOENIX USA; 10232 s. 51st st.; phoenix AZ 85044
• Manufacturer Contact: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 24670655
• Report Number: 0002090040-2026-00006
• Device Sequence Number: 5067325
• Product Code: NLH
• UDI-Device Identifier: 00885825003845
• UDI-Public: 00885825003845
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K030187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: 201101
• Device Catalogue Number: 201101
• Device Lot Number: 5579374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• 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