MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO NASOLARYNGOSCOPE (FOR VIVIDEO)

Model Number VNL9-CP

Device Problem No Display/Image (1183)

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

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd signal wire was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd signal wire.In addition, our technician confirmed that the insertion flexible tube buckled; however, this defect is not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report "hr-rpt-0586 image failure" and/or the risk analysis results, it was evaluated to submit mdr.

Event Description

The time of event is not during procedure.There was no report of patient harm.Video image failure (blackout ).

• Brand Name: PENTAX
• Type of Device: VIDEO NASOLARYNGOSCOPE (FOR VIVIDEO)
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315800
• MDR Report Key: 17028694
• MDR Text Key: 316203064
• Report Number: 9610877-2023-54937
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04961333239795
• UDI-Public: 04961333239795
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K171011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VNL9-CP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1