MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. GREENLINE; LARYNGOSCOPE

Model Number 5-0236-99

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

The customer complaint is confirmed that the pin was missing from one (1) returned handle and could be removed from the second returned handle.Each returned device showed wear and tear from use on the outside and inside portions of the laryngoscope handle.The pin that could be removed did not show deliberate damage or mis-use which is why the investigation has been noted as confirmed without obvious end user error.

Event Description

The customer alleges the "missing pin from handle." no other details were provided and no patient injury/harm reported.

• Brand Name: GREENLINE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• MDR Report Key: 8536424
• MDR Text Key: 142754796
• Report Number: 1314417-2019-00018
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2019

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: No Information
• Device Model Number: 5-0236-99
• Device Lot Number: RK
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1