MAUDE Adverse Event Report: VERATHON MEDICAL ULC CABLE, 4 TO 4 PIN CONNECTORS; LARYNGOSCOPE, RIGID

Model Number 0600-0237

Device Problems Image Display Error/Artifact (1304); Intermittent Energy Output (4025)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device 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.The pgvl system and all its components have not been available for purchase since april 1, 2016 and have not received service nor support since december 31, 2017.

Event Description

The customer reported that during a patient procedure, using a pgvl 4 to 4 pin connector cable, the image was cutting in and out.The customer reported that the cable was damaged and the customer had "fixed" the cable by putting tape over it.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• Brand Name: CABLE, 4 TO 4 PIN CONNECTORS
• 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 ; 6295760
• MDR Report Key: 10146603
• MDR Text Key: 196154541
• Report Number: 9615393-2020-00119
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 0600-0237
• Device Catalogue Number: 0600-0237
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2020
• Initial Date FDA Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention