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

Model Number	BD710FJ282CTRR
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, no relevant visible damage was detected.The device connector, connector pins, handle/ body, shaft, and electrodes appeared to be intact.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 codes: 11, electrical failure - (electrode #1) 46, wave.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause is electrical failure as a result of mishandling, including shipping and storage conditions, subsequent to distribution from stryker.The instructions for use (ifu) state: - do not submerge the proximal handle or cable connector in fluids; electrical performance could be affected.- use both fluoroscopy and electrograms to monitor the advancement of the device to the area of the endocardium under investigation to avoid vascular or cardiac damage.- do not use excessive force to advance or withdraw the catheter.Careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.- do not attempt to operate the catheter prior to completely reading and understanding the applicable instructions for use.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that for the catheter there was a bad electrode cs 9,10.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: 21560473
• Report Number: 0002090040-2025-00016
• Device Sequence Number: 17250852
• Product Code: NLH
• UDI-Device Identifier: 00885825000271
• UDI-Public: 00885825000271
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K100254
• 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): 03/10/2025

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 Expiration Date: 06/01/2025
• Device Model Number: BD710FJ282CTRR
• Device Catalogue Number: BD710FJ282CTRR
• Device Lot Number: 5093361SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 Age: 60 YR
• Patient Sex: Female