MAUDE Adverse Event Report: VERATHON INC. GLIDESCOPE GO; LARYNGOSCOPE, RIGID

Model Number 0570-0366

Device Problems Fracture (1260); Product Quality Problem (1506); Structural Problem (2506)

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

Event Date 09/13/2022

Event Type  Injury  

Event Description

I have used a glidescope go monitor for close to two years.The seam surrounding the monitor wasn't sealed properly.A stress fracture occurred from the seam to an open area located by the button.I attempted to explain to verathon representatives that i never dropped the unit or caused any trauma to the unit.I also only used the af3 wipes recommended by verathon to clean my unit.My biggest concerns are that fluid could slowly enter into the glidescope causing malfunction and rendering it useless and possibly even causing patient harm.The other major concern is risk of infection and transmission of blood-borne diseases secondary to fluid remaining within the glidescope and being transmitted from patient to patient.I repeatedly communicated my concerns to verathon representatives.My concerns were ignored by verathon with a response that i had caused the damage.I reiterated that i never dropped the unit or caused any harm to it and that i only wiped the unit with af3 wipes as instructed by verathon.They reiterated that i must have caused the damage.I went ahead and paid a fee to have my glidescope go replaced by verathon, but my main concern remained.This could be occurring without clinicians knowing and verathon ignored my concern regarding this systemic problem with glidescope go units.The representatives maintained that the damage was cause by me which is incorrect as communicated to them repeatedly.The ultimate victim through all this is the patient as glidescope go units across the world could fail unexpectedly and become vectors for disease transmission.Fda safety report id# (b)(4).

• Brand Name: GLIDESCOPE GO
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON INC.
• MDR Report Key: 15715297
• MDR Text Key: 302936597
• Report Number: MW5113008
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 10/30/2022

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 Model Number: 0570-0366
• Device Catalogue Number: 01 0 0879123 00618 9
• Device Lot Number: (11) 201117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AF3 WIPES
• Patient Outcome(s): Life Threatening