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

Model Number	201101
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently in progress.The investigation results will be submitted in a supplemental mdr.H3 other text : 81.
Event or Problem Description
It was reported the device was broken as the curl had a goose neck shape.However, it was also reported that the device was never put in-situ and there was no harm to patient.The complainant is not aware of any medical intervention or extended procedure time.These are commonly used devices that are readily available.
Event or Problem Description
It was reported the device was broken as the curl had a goose neck shape.However, it was also reported that the device was never put in-situ and there was no harm to patient.The complainant is not aware of any medical intervention or extended procedure time.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.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(s) are: - user error (including user technique and methods).- user expectation of device's curve and it's ability to deflect.- distal tip damage caused by mishandling and/or improper storage.- catheter curve shape inaccurate or kinked.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 attempt to use the reprocessed ep catheter prior to completely reading and understanding the directions for use.¿ do not alter this device.¿ inspect the packaging and catheter for damage or defects prior to use.¿ 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.¿ do not insert or withdraw the catheter without straightening the catheter tip.¿ use fluoroscopic guidance during catheter positioning.Storage and handling: ¿ prior to use, store reprocessed ep catheters in a cool, dry, dark place.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

• 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: 17592717
• Report Number: 0002090040-2023-00012
• Device Sequence Number: 8957079
• Product Code: NLH
• UDI-Device Identifier: 00885825003845
• UDI-Public: 00885825003845
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030187
• 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,Followup
• Report Date (Section B): 10/13/2023

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: 05/15/2025
• Device Model Number: 201101
• Device Catalogue Number: 201101RR
• Device Lot Number: 5078357SH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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