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

Model Number ECY-150S

Device Problem Structural Problem (2506)

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

Event Type  Injury  

Manufacturer Narrative

This product is not available for sale in the usa international medical device regulators forum (imdrf) adverse event reporting: (b)(4).

Event Description

Pentax medical was made aware of a complaint that occurred in the operating room during use in (b)(4).The reported complaint that "the scope insertion part was torn and fell into the body, and the fallen debris was taken out with forceps", involving the pentax product, model ecy-150s.No serious injury or death of a patient or user was reported.However, the information reasonably suggests that if the malfunction recurs while in use with pentax product is likely to cause or contribute to a death, serious injury, or other significant/important medical event as defined in 21 cfr 803, therefore this event is fda reportable.The manufacture statement is as follows: "december 16, 2020 i was informed that i could not see the endoscopic image.To check the situation, visit the person in charge at the store after the medical examination and check the situation.During the inspection from dr, the scope insertion part was torn and fell into the body, and the fallen debris was taken out with forceps.I think i've removed everything.Arrange a substitute and plan to visit after arrival.December 18, 2020 visited to replace alternative machines.Confirmation of the situation at the time of failure with the nurse who was present at the inspection.Replace with a substitute machine and bring back the broken equipment and the dropped debris." on 26feb2021, an investigation was completed under ivai-21-010016, the findings is as follows: "it was confirmed that the black glue on both ends of bending rubber had peeling or chipping.It is probable that the epoxy glue had deteriorated due to eto sterilization.Since the user used the endoscope without performing pre-use inspection, it is presumed that the debris fell off due to contact with the patient's body." on 05jan2021, a device history record(dhr) review for model ecy-150s, serial number h110369 was performed under ivai-20-120062, the dhr review confirmed the device was manufactured on 12-jul-2016 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.

• Brand Name: PENTAX
• Type of Device: VIDEO CYSTO SCOPE
• 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 11515805
• MDR Text Key: 240769919
• Report Number: 9610877-2021-00057
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECY-150S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR