MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA COLONOSCOPE

Model Number EC38-I10F

Device Problems Corroded (1131); Erratic or Intermittent Display (1182); Fluid/Blood Leak (1250); Poor Quality Image (1408); Premature End-of-Life Indicator (1480)

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

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

The nurse connected the scope on the processor, the image was abnormal, which caused by corrosion and oxidation of the ae-p1 lead to signal transmission problems.The scope was leaked, the light carrying bundle was fractured which caused insufficient light.This event occurred at the time of before use.There was no report of patient harm.

Manufacturer Narrative

Correction information: g6: follow up #1, h2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information: h4:device manufacture date.D8: was this device serviced by a third party? evaluation summary: the pentax engineer checked with hospital staff.The defect was found during pre-use inspection.No harm was caused to the patient.The seals of pve soaking cap was poor, resulting in pve metal needle corrosion, then no image and leakage happened.The light carrying bundle was fractured which caused insufficient light.The scope was repaired by the third party and returned to the hospital.Replaced the pve soaking cap.

• Brand Name: PENTAX
• Type of Device: IMAGINA COLONOSCOPE
• 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 ; 8004315880
• MDR Report Key: 15415730
• MDR Text Key: 302865312
• Report Number: 9610877-2022-00564
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC38-I10F
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1