MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM LOPRO S4; LARYNGOSCOPE, RIGID

Model Number 0574-0195

Device Problems Mechanical Problem (1384); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated; however, at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

The customer reported that during a patient procedure, using a glidescope spectrum lopro s4, when the lopro s4 was plugged into the smart cable and gvm monitor, the light did not turn on.The initial complaint stated that no back-up device was used, however a subsequent letter from the fda states: "a new scope was retrieved and used successfully".No harm to the patient or user was reported.

• Brand Name: GLIDESCOPE SPECTRUM LOPRO S4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 12658557
• MDR Text Key: 279814026
• Report Number: 9615393-2021-00315
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0574-0195
• Device Catalogue Number: 0270-0939
• Device Lot Number: GU78180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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