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

Model Number	81104RR
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
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 catheter shaft, handle/ body, deflection and locking mechanism appeared to be intact.The device was evaluated for deflection.The catheter did not meet the curve specification.The device was evaluated using plane template.The device did not meet the planarity specification.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 a catheter curve issue as a result of mishandling subsequent to distribution, including shipping/ storage conditions or improper manipulation of the device.The instructions for use (ifu) state: - do not exert excessive pressure during placement of catheter if unknown resistance is encountered.- do not attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use.- avoid manual pre-bending of distal curve, as this may damage steering mechanism of steerable catheters.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the item did not deflect properly.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: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 21562228
• Report Number: 0002090040-2025-00021
• Device Sequence Number: 4430489
• Product Code: NLH
• UDI-Device Identifier: 00885825009557
• UDI-Public: 00885825009557
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• 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: 05/08/2025
• Device Model Number: 81104RR
• Device Catalogue Number: 81104RR
• Device Lot Number: 5072533SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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 Sex: Unknown