MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE VIDEO CABLE; LARYNGOSCOPE, RIGID

Model Number 0600-0771

Device Problems No Display/Image (1183); Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896)

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

Event Date 03/18/2022

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope core smart cable with a glidescope core 10-inch monitor, the signal drops out when the connected glidescope "handpiece" was manipulated.The customer states there's a "defect" at the connection point between the smart cable and glidescope "handpiece".No delay in the reported procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

Upon follow-up with the customer to get more information on the reported device, the customer was unable to identify the exact cable or "handpiece" used during the patient procedure but did confirm it could be one of three cables at their facility.The customer confirmed the first cable had already been disposed of at their facility, while the remaining two cables will be returned to verathon for investigation.The devices 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.

Manufacturer Narrative

On initial follow-up with the customer to get more information on the reported device, the customer was unable to identify the exact cable or "handpiece" used during the patient procedure.The customer did confirm it could be one of three cables at their facility.The customer confirmed the first cable had already been disposed of at their facility, while the remaining two (2) cables will be returned to verathon for investigation.Verathon received two (2) glidescope core video cables for evaluation on april 14, 2022 that may have been used during the reported patient procedure.Based on the verathon cables received, the following information for cable type has been corrected in the following final report from glidescope core smart cable (0600-0783) to glidescope core video cable (0600-0771).A verathon technical service representative evaluated the returned cables but was unable to confirm the reported issue.When connecting the first returned glidescope core video cable to known, good, test verathon equipment, the image and functionality was normal.The verathon technical service representative next connected the second returned glidescope core video cable to known, good, test verathon equipment, and the image and functionality was also found to be normal.The camera image quality test was performed and passed for both glidescope core video cables returned for investigation.The verathon technical service representative confirmed both glidescope core video cables were functioning as intended; no issues found.Upon completion of the evaluation of the returned glidescope core video cables, verathon contacted the customer with follow-up questions and information based on the evaluation findings.The customer responded but was unable to provide any additional information to determine root cause of the issue.Per request of the customer the following glidescope core video cables were returned back to their facility.No further investigation is required at this time.Verathon will continue to monitor for any ongoing trends.

• Brand Name: GLIDESCOPE CORE VIDEO CABLE
• 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: 14014700
• MDR Text Key: 298395346
• Report Number: 9615393-2022-00058
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600-0771
• Device Catalogue Number: 0800-0604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1