MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME ZOOM STRETCHER, ELECTRIC; STRETCHER, WHEELED, POWERED

Catalog Number	1125000000E
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.24 device(s) was functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.1 device was not evaluated, as a probable cause for the issue was identified during communication between the customer and stryker and no further assistance was requested by the customer.3 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.3 devices are pending evaluation.Evaluation results findings (components/results): 3 devices: appropriate term/code not available / no findings available.1 device: circuit board / electrical/electronic component problem identified.1 device: circuit board; sensor / electrical/electronic component problem identified.22 devices: sensor / electrical/electronic component problem identified.1 device: sensor / device migration.3 devices: appropriate term/code not available / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1-september 30, 2025.This report summarizes 31 malfunction event(s), where it was reported the device experienced unintended direction of the zoom; unintended motion or unintended excessive speed of the zoom.There was 1 event with patient involvement; the patient experienced pain, but no serious adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
1 device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results).1 device: sensor/electrical/electronic component problem identified.1 device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Evaluation results findings (components/results).1 device: appropriate term/code not available/no findings available.1 device that was pending was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.
Event or Problem Description
This report now summarizes 30 malfunction event(s), instead of 31.

• Brand Name: PRIME ZOOM STRETCHER, ELECTRIC
• Common Device Name: STRETCHER, WHEELED, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 23393416
• Report Number: 0001831750-2025-99389
• Device Sequence Number: 18653684
• Product Code: INK
• UDI-Device Identifier: 07613327278286
• UDI-Public: 7613327278286
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 30
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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
• Device Catalogue Number: 1125000000E
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown