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

Model Number	MDS0425615
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1417592-2022-00130
• Device Sequence Number: 12162889
• Product Code: CCW
• UDI-Device Identifier: 10889942563708
• UDI-Public: 10889942563708
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

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