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

Model Number	81202
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Functional testing 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 relevant reject code of cp, curve out of plane.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 an electrical failure as a result of mishandling subsequent to distribution from stryker.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 autoclave catheter.- do not use for electrical ablation.- if electrocardiogram equipment is used for placement of the catheter, the equipment must be front-end isolated of have an isolated patient cable.Current leakage from the electrocardiogram monitor must not exceed 10 microamps.- 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.
Event or Problem Description
It was reported the catheter was showing electrical signals not responding to deflection.There was no patient injury or medical intervention and extended procedure time reported was two minutes.These are commonly used devices that are readily available.

• 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: 16604395
• Report Number: 0002090040-2023-00003
• Device Sequence Number: 14729937
• Product Code: NLH
• UDI-Device Identifier: 00885825009816
• UDI-Public: 00885825009816
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 03/23/2023

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 Expiration Date: 10/14/2024
• Device Model Number: 81202
• Device Catalogue Number: 81202RR
• Device Lot Number: 4898160SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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: Female
• Patient Race: White