MAUDE Adverse Event Report: SUNMED SUNMED; GREENLINE D F/O LED LARGE HANDLE

Model Number 5-0236-69

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer Narrative

Pieces of the handle fell into the patient's mouth and had to be retrieved by anesthesia staff during intubation.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.

Event Description

Laryngoscope handle shattered during use.Pieces of the handle fell into the patients mouth and had to be retrieved by anesthesia staff during intubation.

Manufacturer Narrative

Pieces of the handle fell into the patient's mouth and had to be retrieved by anesthesia staff during intubation.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.Complaint history reviewed.There have been 2 previous complaints for this issue in the previous 24 months.Ncmr-02423 was issued to conduct 100% sort to confirm complaint.Defect was found to have a rate of 1/4360.Supplier investigation into complaint did not find root cause, however supplier has requested a change in resin to reduce the occurrence of this issue.Risk (rma-20002b): r5: plastic heel breaking - torsion or tensile forces - s=7, o=2, rpn=14.Rpn < 25, therefore risk is acceptable.

Event Description

Laryngoscope handle shattered during use.Pieces of the handle fell into the patients mouth and had to be retrieved by anesthesia staff during intubation.

• Brand Name: SUNMED
• Type of Device: GREENLINE D F/O LED LARGE HANDLE
• Manufacturer (Section D): SUNMED; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 13518408
• MDR Text Key: 288183635
• Report Number: 1314417-2022-00004
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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
• Device Operator: Health Professional
• Device Model Number: 5-0236-69
• Device Lot Number: 20X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other