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

Model Number 0574-0195

Device Problem Break (1069)

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

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The customer disposed of the broken device.The customer did not provide the lot number for the glide scope spectrum lopro s4 so the device history record is unknown.At this time, the cause of the reported issue cannot be determined.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

The customer reported that during a patient procedure, using a glide scope spectrum lopro s4, the final one (1) inch of the blade broke off in the patient's mouth.The customer stated that he had never resterilized the blade and that he was able to "fish" the broken piece out of the patient's mouth quickly before switching to another blade.The customer stated that he disposed of the damaged blade before using another one.A delay in the procedure of a few seconds occurred before switching the glidescope spectrum lopro s4 out with another blade.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
• 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 98011-8218 ; 4256295760
• MDR Report Key: 10580760
• MDR Text Key: 208351965
• Report Number: 9615393-2020-00193
• 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: other
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• 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