MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP HANDLE,LARYNG,LED,FO,DISP,SML,2CM DIAM

Model Number MDS0425615

Device Problem Break (1069)

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

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported that the laryngoscope broke during intubation.The facility reported that they did not have any of the patient or incident details however there was no patient injury noted, and another device was able to be utilized.

Manufacturer Narrative

It was reported that the laryngoscope broke during intubation.The facility reported that they did not have any of the patient or incident details however there was no patient injury noted, and another device was able to be utilized.The facility stated that the broken handle was disposed of and is not available to be returned for evaluation.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: HANDLE,LARYNG,LED,FO,DISP,SML,2CM DIAM
• Type of Device: HANDLE,LARYNG,LED,FO,DISP,SML,2CM DIAM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15153588
• MDR Text Key: 297132637
• Report Number: 1417592-2022-00130
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 10889942563708
• UDI-Public: 10889942563708
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDS0425615
• Device Catalogue Number: MDS0425615
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other