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

Model Number	BD710DF282RTS
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	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the device shaft maintained a significant bend due to the shipping method.No further relevant visible damage was detected the catheter handle, steering knob, locking mechanism, connector, and electrodes appeared to be intact.The device met specification for curve and planarity in the d and f directions.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: user error (including user technique and methods).User anticipation/ expectation of device's curve shape (including the expectation of the device's ability to maneuver or flex).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 use excessive force to advance or withdraw the catheter.Careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.Inspect the catheter for overall condition and physical integrity.Do not use the catheter if electrodes appear loose or if any damage is noted.If such problems exist, return the catheter and packaging to stryker sustainability solutions.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the steerable mechanism was exaggerated on one side vs.The other.As an illustrative example, when turned 10 degrees left, the catheters curved 25 degrees whereas when turned 10 degrees right, the catheter curved 10 degrees.There was no patient injury, medical intervention, or extended procedure time reported.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: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 23721799
• Report Number: 0002090040-2025-00044
• Device Sequence Number: 8421030
• Product Code: NLH
• UDI-Device Identifier: 00885825000264
• UDI-Public: 00885825000264
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/04/2025

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: BD710DF282RTS
• Device Catalogue Number: BD710DF282RTS
• Device Lot Number: 5530000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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