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

Model Number	401223
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Open or Remove Packaging Material (2922); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer was facing a few issues with the catheter.As reported, the catheter barely come out of the transparent sleeve, the shape is not as normal, they are more "wrinkled" than usual and don¿t keep their basic shape.There was no patient injury or medical intervention and extended procedure time reported was a few minutes.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the customer was facing a few issues with the catheter.As reported, the catheter barely come out of the transparent sleeve, the shape is not as normal, they are more "wrinkled" than usual and don¿t keep their basic shape.There was no patient injury or medical intervention and extended procedure time reported was a few minutes.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.It was stated that the device was not saved for investigation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr (device history record) could not be performed as the lot and serial numbers were not reported or obtainable.Stryker procedure(s) support(s) that the device was unlikely to have been released from stryker with the reported failure mode.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.Avoid excessive contact of handpiece with fluids, as this could adversely affect the electrical performance of the catheter.Do not insert or withdraw the catheter without straightening the catheter tip.Storage and handling: 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.Should the device become available for return, the investigation will be reopened.

• 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: 20940700
• Report Number: 0002090040-2024-00026
• Device Sequence Number: 8135752
• Product Code: NLH
• UDI-Device Identifier: 00885825005818
• UDI-Public: 00885825005818
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K030026
• 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): 02/18/2025

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: 401223
• Device Catalogue Number: 401223
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/18/2025
• 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