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

Model Number	81104
Medical Device Problem Codes	Use of Device Problem (1670); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the ep catheter failed.As reported, the device was replaced with a stryker device.There was no patient injury or medical intervention and extended procedure time was reported, however the complainant is not aware of the duration.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, damage to the catheter shaft was observed.Inspection of the device shaft revealed two deformations, a kink and a bend.The kink was located (approximately) 7 cm, and the bend was located (approximately) 12 cm from the distal tip.No further relevant visible damage was observed.The catheter connector, handle, deflection, locking mechanisms, and electrodes appear intact.The location of the shaft deformations (kink/ bend) was identified using a calibrated steel ruler.The catheter met the planarity specification.Further functional inspection was performed via inline testing.Given the reported event, per re-inspection documentation, the device was found to be eligible for rejection based on the following relevant reject code: improper curve.As the complaint device was confirmed to have two shaft deformations during re-inspection, it is likely that the deformations found near the distal tip contributed to the customer's reported event as damage to the device's structural integrity may adversely impact its mechanical and electrical qualities.Therefore, the inspection results indicated that the complaint is confirmed for the reported failure mode.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to mishandling subsequent to distribution, including shipping and storage conditions or improper manipulation of the device.The instructions for use (ifu) state: 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.Standard electrical grounding precautions should be observed when using electrical recording or stimulation equipment.Avoid excessive contact of handpiece with fluids, as this could adversely affect the electrical performance of the catheter.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: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 22783749
• Report Number: 0002090040-2025-00039
• Device Sequence Number: 21287746
• Product Code: NLH
• UDI-Device Identifier: 00885825009557
• UDI-Public: 00885825009557
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112232
• 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): 08/12/2025

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: 81104
• Device Catalogue Number: 81104
• Device Lot Number: 5485298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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