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

Model Number	81104
Medical Device Problem Codes	Use of Device Problem (1670); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter had a warped curve.As reported, the device was replaced.There was no patient injury or medical intervention and extended procedure time reported was five minutes.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 the catheter's curve deflection mechanism (and locking dial) engaged.Upon visual inspection of the received complaint device, no (further) relevant visible damage was observed.Due to the improper return, the device was considered to be ineligible for functional testing.The complaint device's curve mechanism was received engaged and in a locked position, likely stressing the catheter's internal wiring for the duration of its return to stryker (10 calendar days).As the complaint device was returned to stryker via improper shipping methods, the reported event experienced by the customer could not be confirmed as the manner of which the complaint device returned may adversely impact its functional testing and root cause analysis.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.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: N/A
• 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: 21428581
• Report Number: 0002090040-2025-00008
• Device Sequence Number: 4361091
• Product Code: NLH
• UDI-Device Identifier: 00885825009557
• UDI-Public: 00885825009557
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 02/20/2025

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: 5435334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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