MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME ZOOM STRETCHER30INLITTER; STRETCHER, WHEELED, POWERED

Catalog Number	1125000030
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 january 1- march 31, 2026.This report summarizes 21 malfunction events(s), where it was reported the devices experienced unintended direction of the zoom; unintended motion or unintended excessive speed of the zoom.No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.18 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.Evaluation results findings (components/results).1 device: pusher / mechanical problem identified.1 device: pusher / wear problem.16 devices: sensor / electrical/electronic component problem identified.3 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.Evaluation results findings (components/results).3 devices: appropriate term/code not available/no findings available.There was no remedial action taken.This device is not labeled for single use.

• Brand Name: PRIME ZOOM STRETCHER30INLITTER
• 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: 24966104
• Report Number: 0001831750-2026-99215
• Device Sequence Number: 12006771
• Product Code: INK
• UDI-Device Identifier: 07613327278293
• UDI-Public: 7613327278293
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 21
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: 1125000030
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/23/2026
• 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