MAUDE Adverse Event Report: VERATHON MEDICAL ULC SPECTRUM BLADE; LARYGNGOSCOPE, RIGID

Model Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Output Problem (3005)

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

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The return of the glidescope avl monitor and the glidescope spectrum smart cable are anticipated, however; at the time of the report, the devices have 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 avl monitor, a glidescope spectrum smart cable and an unknown disposable blade, there was an intermittent image.A verathon sales representative stated that the single-use blade was thrown away.He also stated that he tested all the smart cables with a spectrum blade and all were working fine.The sales representative believes that "potentially the blade handle was held too high 'at or near the smart cable spectrum blade connection area'.And during lifting or torquing forward the picture went intermittent due to a slight disconnect of hdmi and blade handle." "[the sales representative] has talked to the [anesthesia] provider.About proper technique twice now.If she is in fact holding and lifting improperly, she seems to be unaware of it or not thinking that this is the issue." no delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• Brand Name: SPECTRUM BLADE
• Type of Device: LARYGNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, wa ; 6295760
• MDR Report Key: 10420104
• MDR Text Key: 203869942
• Report Number: 9615393-2020-00170
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2020

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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