MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GVL SINGLE USE STAT; LARYNGOSCOPE, RIGID

Model Number 0270-0628

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

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 gvl single use size 4 stat, the tip broke off in the patient's mouth.The stat and the broken portion of the stat were removed from the patient.The customer indicated the procedure was completed; however, type of device used to complete the procedure and the length of time to prepare the second device were not reported.No harm to the patient or user was reported.

Manufacturer Narrative

The customer returned two samples of their glidescope gvl single use size 4 stats to verathon for evaluation.A verathon technical service representative evaluated the returned stats where they were able to verify the reported damage.It was found that the ends of the stats had broken off inside the packaging.The returned stats were forwarded to the contract manufacturer for further evaluation.The contract manufacturer evaluated the returned stats where they confirmed the damage to the unit.A visual inspection of the stat was performed and no obvious signs of stress on the stat were observed.The pouch showed minor signs of stress, including a small puncture, indicating potential damage during shipment; however, there were no obvious blow outs or tears in the pouches.The contract manufacturer load tested all available retained samples from this lot and all stats passed inspection.The retain samples were re-measured to inspect for any possible thin sections of the stat.There were no out-of-specification or outlying measurements noted.The machine settings for all retain molding runs were reviewed and all settings were within specification.The sterilization process was also reviewed, and all applied minimum and maximum doses were normal.The contract manufacturer and verathon were unable to definitively determine a root cause for the breaks observed.No corrective action is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE GVL SINGLE USE STAT
• 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: 8444316
• MDR Text Key: 139582056
• Report Number: 9615393-2019-00058
• 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,Followup
• Report Date: 02/22/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: 0270-0628
• Device Catalogue Number: 0270-0628
• Device Lot Number: GF49538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 08/04/2019
• Supplement Dates FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1