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

Model Number	0574-0195
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported in the following medwatch form manufacturer report number "mw5111876" that during a patient procedure, using a glidescope spectrum single-use lopro s4, the video goes out on insertion into the airway.The provider was experienced, and completed the intubation without the use of the scope.No delay in the procedure or harm to the patient was reported.
Additional Manufacturer Narrative
Verathon investigated the reported medwatch form manufacturer report number "mw5111876" but was unable to verify if the reported glidescope spectrum single-use lopro s4 will be made available to verathon for evaluation at this time.No further information was found or provided on the reported verathon device.If further information however does become available for the following device, a supplemental report will be submitted in accordance with 21 cfr 803.56.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S4
• Common Device Name: 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: 15496436
• Report Number: 9615393-2022-00170
• Device Sequence Number: 5825172
• Product Code: CCW
• UDI-Device Identifier: 10879123006230
• UDI-Public: 011087912300623010JF1280169417250304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2025
• Device Model Number: 0574-0195
• Device Catalogue Number: 0270-0939
• Device Lot Number: JF12801694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown