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

Catalog Number 1089000000

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Eye Injury (1845); Laceration(s) (1946)

Event Date 01/22/2018

Event Type  Injury  

Event Description

It was reported that during a corneal transplant the surgeon asked the nurse to place the patient in trendelenburg position (feet higher than head).Due to the edge of the operative field and the devices around the patient, the nurse was not able to easily access the pedal, and pushed the wrong part of the trifunctional pedal.This resulted in the patient being placed in a reverse trendelenburg position (head higher than feet), resulting in a laceration to the patient's eye.It was reported the functional prognosis is not favorable.The procedure was delayed for an unknown amount of time.The patient required an extended hospital stay with medical treatment.There was no reported malfunction of the device.

Manufacturer Narrative

Updated based on device evaluation.Device not available for evaluation.

Event Description

It was reported that during a corneal transplant the surgeon asked the nurse to place the patient in trendelenburg position (feet higher than head).Due to the edge of the operative field and the devices around the patient, the nurse was not able to easily access the pedal, and pushed the wrong part of the trifunctional pedal.This resulted in the patient being placed in a reverse trendelenburg position (head higher than feet), resulting in a laceration to the patient's eye.It was reported the functional prognosis is not favorable.The procedure was delayed for an unknown amount of time.The patient required an extended hospital stay with medical treatment.There was no reported malfunction of 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7575485
• MDR Text Key: 110329485
• Report Number: 0001831750-2018-00523
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1089000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2018
• 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