MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO EYE SURGERY STRETCHER; STRETCHER, WHEELED

Catalog Number	1089000000
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 21 malfunction events(s), where it was reported the devices experienced drifting down slowly.There was 1 event with patient involvement; the patient experienced pain.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.12 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.5 devices were 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.1 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes now 22 malfunction events(s), instead of 21.
Additional Manufacturer Narrative
An additional event was identified and therefore, added to this summary report.The 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.Mdr/mir codes have been updated to reflect this.
Event or Problem Description
This report summarizes now 23 malfunction events(s), instead of 22.
Additional Manufacturer Narrative
An additional event was identified and therefore added to this summary report.
Additional Manufacturer Narrative
1 device that was originally coded as not made available by the customer was found that it was evaluated in the field and the issue was confirmed.Mdr/mir codes have been updated to reflect this.Evaluation results findings (results/components): 1 device: mechanical problem identified/chassis/frame.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
1 device that was originally coded as not made available by the customer was found that it was evaluated in the field and the issue was not confirmed; no defect or malfunction was found.
Event or Problem Description
This report now summarizes 22 malfunction events(s), instead of 23.

• Brand Name: EYE SURGERY STRETCHER
• Common Device Name: STRETCHER, WHEELED
• 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: 22577272
• Report Number: 0001831750-2025-99083
• Device Sequence Number: 21278203
• Product Code: FPO
• UDI-Device Identifier: 07613327278170
• UDI-Public: 7613327278170
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 22
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/07/2026

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: 1089000000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 07/01/2025; 07/01/2025; 07/01/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 07/28/2025; 09/17/2025; 09/25/2025; 01/07/2026
• 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