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

Model Number 1089

Device Problem Device Fell (4014)

Patient Problems Eye Injury (1845); Insufficient Information (4580)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported that the headrest collapsed during ophthalmology operation.It was further reported that as a result, the patient underwent retinal surgery later the same evening.Further information has not been provided yet.Attempts are being made to gather more details from the user facility.

Manufacturer Narrative

The investigation is complete, section h codes have been updated to reflect the results.

Event Description

It was reported that the headrest collapsed during ophthalmology operation.It was further reported that as a result of the collapse, the patient sustained a retinal injury which required revision surgery.Upon evaluation, it was discovered that there were no functional issues with the headrest that caused or contributed to the alleged headrest collapse.

• 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12760483
• MDR Text Key: 281743303
• Report Number: 0001831750-2021-01623
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278170
• UDI-Public: 07613327278170
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: No
• 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