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

Model Number EPK-I7000

Device Problems No Display/Image (1183); Loose or Intermittent Connection (1371)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

This device is not distributed in us so that 510k is blank.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

On (b)(6) 2023, at 14:30, in the fourth operating room , when the colonoscope entered to the transverse colon, the physician was found that the image screen suddenly appeared blackout with half of the screen, and the power-on function showed blue brightness.The physician immediately stopped the operation and kept the position of the colonoscope unchanged, and the nurse restarted the processor to no avail, and then reconnected the scope and processor, the screen was displayed normally and completed the examination.After the examination, the nurse contacted the engineer to inspect the defective processor, and initially judged that it might be a loose screw of the fixed lock of the processor, resulting in image failure.This defect did not cause any harm to the patient, but prolonged the examination time of the patient.There was no report of patient harm.This event occurred at the time of during use.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.).

Manufacturer Narrative

Correction information: b4: date of this report.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: d4:unique identifier (udi).H4:device manufacture date.Evaluation summary: the pentax engineer checked with hospital staff.The device was used for examination.No harm was caused to the patient.After reconnected the scope and processor, it could be used normally and completed the examination.The endoscope locking lever was loose.Loose connection between the endoscope and the processor leads to poor contact, which caused image problems.Based on the findings data, we determined that the potential/root cause of the failure was due to loosening of the scope lock lever over time.The hospital's engineer reinforces the endoscope locking lever.Reminded the hospital that they should pay attention to pre-use check which can reduce the occurrence of accidents.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical penang on 11-jan-2017 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed on 11-jan-2017.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO PROCESSOR
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 17187959
• MDR Text Key: 317821148
• Report Number: 9610877-2023-00173
• Device Sequence Number: 1
• Product Code: PEA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPK-I7000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1