MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO ENT SCOPE

Model Number VNL-1570STK

Device Problem Corroded (1131)

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

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis: model name: vnl-1570stk serial number: (b)(4) the hospital installed i7000+vnl-1570stk on jan.15 2020 and report that the cover of the lg prong was damaged which includes discolored and corroded.Then changing the cover of the lg prong triple times.Fse engineer visited the hospital and didn't find any obvious scratches on the scope connection and lg prong but that it was seriously worn.The user asked the repair and equipped another scope connection.The cover of lg prong not tolerant to peracetic acid (not the recommended chemistory) and lg prong had friction with light sources.After replacing lg prong, it appeared the corroded and scratches.It was judged by that the axis of the mirror guide rod is deviated.In addition, the corrosion from the chemistory which caused the corrosion of the cover of lg prong.No harm was caused.This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

Event Description

Pentax medical was notified that a customer observed that the light prong was corroded.The issue was noted in the reprocessing room.There was no report of patient injury.

• Brand Name: PENTAX
• Type of Device: VIDEO ENT SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12356774
• MDR Text Key: 283156844
• Report Number: 9610877-2021-00107
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• PMA/PMN Number: K162151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 08/23/2021

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: No Information
• Device Model Number: VNL-1570STK
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1