MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER G.I.SCOPE

Model Number EG29-I10

Device Problems Fracture (1260); Poor Quality Image (1408); Unintended Movement (3026)

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

The angle could not be rotated, it influenced observation.Harm performance: influence observation and prolonged time this event occurred at the time of during pre-use inspection.There was no report of patient harm.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

Pentax medical apac performed good faith efforts to gather additional information regarding this event and provided an email response on 31-jan-2024 for the following questions.Q1.Was the procedure prolonged enough to cause major problems at the hospital? a: no, the hospital just think that replace the device will prolong the time.Q2.Was the procedure completed with another endoscope? a: it was found during pre-use check, the user completed the examination with other scope.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary the pentax engineer checked with hospital staff.The defect was found during pre-use check.No harm was caused to the patient.The examination was completed with other device.The angle wire was fractured due to excessive force when operating the angle knob.The device was repaired by the third party and returned to the hospital.Reminded the hospital that when using endoscopes, it is important to follow the instructions in the pentax manual.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 20-may-2019 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 (b)(6) 2019.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 UPPER G.I.SCOPE
• 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 196-0 012; JA 196-0012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18655968
• MDR Text Key: 334885074
• Report Number: 9610877-2024-00008
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131902
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1