MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; F/O GREENLINE D MAC SIZE 3

Model Number 5-5332-03

Device Problem Material Fragmentation (1261)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

Potential of aspiration of a foreign object.Investigation is ongoing.

Event Description

During intubation a portion of the fiber bundle separated and fell into the patient's pharynx and landed on top of the vocal cords.This was recovered and intubation proceeded successfully with replacement blade with no harm to the patient.

Event Description

N/a.

Manufacturer Narrative

Potential of aspiration of a foreign object.Investigation is ongoing.The complaint of "a portion of the fiber bundle separated and fell off" regarding part 5-5332-03 was confirmed via photo.The root cause cannot be determined but could possibly be a result of torsion, shear, or tensile forces.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been 2 other complaints against this part in the 24 months preceding this complaint.0 of those complaints were regarding a similar issue.A resolution letter was sent to the customer.

• Brand Name: SUNMED LLC
• Type of Device: F/O GREENLINE D MAC SIZE 3
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 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: 18251451
• MDR Text Key: 330246708
• Report Number: 1314417-2023-00027
• 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: 12/01/2023

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: 5-5332-03
• Device Catalogue Number: 5-5332-03
• Device Lot Number: 243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other