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

Catalog Number 1089000000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2023

Event Type  malfunction  

Event Description

This report summarizes 9 malfunction events, where it was reported the devices experienced fluid leaks onto floor.There was 1 event with patient involvement no adverse consequences were reported.

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.8 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Manufacturer Narrative

The device pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Section h codes have been updated to reflect this.

Event Description

This report summarizes 9 malfunction events, where it was reported the devices experienced fluid leaks onto floor.There was 1 event with patient involvement no adverse consequences were reported.

• Brand Name: EYE SURGERY STRETCHER
• Type of Device: 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17407145
• MDR Text Key: 319879493
• Report Number: 0001831750-2023-00957
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278170
• UDI-Public: 07613327278170
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 9
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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
• Device Catalogue Number: 1089000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 07/01/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1