MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. SUNONE SYSTEM SINGLE PATIENT USE LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Catalog Number 5-0236-69

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

During intubation, laryngoscope handle broke.Four small pieces handle broke off around pt airway.

• Brand Name: SUNONE SYSTEM SINGLE PATIENT USE LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): SUNMED HOLDINGS, LLC.; 2710 northridge dr, nw; ste a; grand rapids MI 49544
• MDR Report Key: 12975683
• MDR Text Key: 282123769
• Report Number: MW5105946
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 5-0236-69
• Device Lot Number: 20X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2021
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 75 KG