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

Model Number VNL9-CP

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Event Description

Pentax medical was made aware of a complaint which occurred in the united states with the description of "no video/error msg, scope not conn." involving pentax medical endoscope model vnl9-cp, serial number (b)(4).The customer owned endoscope was received by pentax medical for evaluation on 09-aug-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician found image blackout confirming the customer complaint and also documented the following inspection findings: control body vivideo signs of severe corrosion, passed dry leak test, passed wet leak test, ift assy with bending rubber bukcle at end of rootbrace, control body vivideo signs of fluid invasion.The device underwent repairs including the following components: o-rings and seals, ift assy w/bending rubber, rs2 control button with pcb, r2s module, r2s led module, umbilical cable w/o jst connector, jst connector (set of 20pcs), r2s switch cable, r2s led module.Model vnl9-cp, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.The endoscope is awaiting repair and approved by final qc as of 03-sep-2021.

Manufacturer Narrative

(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

• 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
• MDR Report Key: 12421631
• MDR Text Key: 281287791
• Report Number: 9610877-2021-00575
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04961333239795
• UDI-Public: 04961333239795
• Combination Product (y/n): N
• PMA/PMN Number: K171011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 09/03/2021

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: VNL9-CP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1