MAUDE Adverse Event Report: SALTER LABS SALTER LABS; DISPOSABLE PEDIATRIC HANDLE-FIBER OPTIC

Model Number	6016.C
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The lights were so dim they could not see down a patient throat.
Additional Manufacturer Narrative
The light going out during intubation would cause a disruption in patient therapy.The clinician would need to find a handle and blade that work further delaying the intubation and patient therapy.
Additional Manufacturer Narrative
The light going out during intubation would cause a disruption in patient therapy.The clinician would need to find a handle and blade that work further delaying the intubation and patient therapy.The complaint of "lights not coming on, multiple laryngoscope handles" regarding part 2016.C was confirmed.The root cause could possibly be a result of faulty electrical connectivity.A risk assessment was performed, and the ultimate risk was determined to be medium.Capa-00510 is currently open for this issue.There have been 8 other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
The lights were so dim they could not see down a patient throat.

• Brand Name: SALTER LABS
• Common Device Name: DISPOSABLE PEDIATRIC HANDLE-FIBER OPTIC
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19136204
• Report Number: 3000219639-2024-00037
• Device Sequence Number: 15188023
• Product Code: CCW
• UDI-Device Identifier: 00607411964459
• UDI-Public: 00607411964459
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: 6016.C
• Device Catalogue Number: 6016.C
• Device Lot Number: 2024-01-10-GSADPS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown