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

Model Number 1089

Device Problem Device Fell (4014)

Patient Problem Retinal Injury (2048)

Event Date 05/13/2022

Event Type  Injury  

Event Description

It was reported that during surgery, the head rest collapsed/dropped.It was further reported that when the head rest collapsed, the instrument hit the retina and caused bleeding.Attempts are being made to gather additional injury and treatment details from the user facility.

Manufacturer Narrative

The device was evaluated by a field service representative and no defect was found.B5 and section h codes have been updated to reflect the investigation.

Event Description

It was reported that during surgery, the head rest collapsed/dropped.It was further reported that when the head rest collapsed, the instrument hit the retina and caused bleeding.The patient needed to be in surgery longer to correct the issue.The device was evaluated by a field service representative and no defect was found with the device.

• 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: melissa millard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 14604834
• MDR Text Key: 293378263
• Report Number: 0001831750-2022-00589
• 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: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1089
• Device Catalogue Number: 1089000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2018
• 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
• Patient Outcome(s): Other