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

Model Number	BD710FJ282RTS
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation as the customer lost the device.As the complaint device was not returned for evaluation, a conclusive root cause could not be determined and the customer's reported event could not be confirmed.A review of the device history record (dhr) could not be performed as the lot and serial numbers were not reported or obtainable.Stryker procedure(s) supports 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 operate the catheter prior to completely reading and understanding the applicable instructions for use.Do not submerge the proximal handle or cable connector in fluids; electrical performance could be affected.Always place the rocker lever in the neutral position to straighten the catheter tip before insertion or withdrawal of the device.Do not use excessive force to advance or withdraw the catheter.Careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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.Tactile feedback of reprocessed devices may vary during use.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported that the knobs on catheter did not work.There was no patient injury and the complainant is not aware of any medical intervention or extended procedure time.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: 19637946
• Report Number: 0002090040-2024-00006
• Device Sequence Number: 12536062
• Product Code: NLH
• UDI-Device Identifier: 00885825000288
• UDI-Public: 00885825000288
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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: BD710FJ282RTS
• Device Catalogue Number: BD710FJ282RTS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2024
• Initial Report FDA Received Date: 06/28/2024
• 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