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U.S. Department of Health and Human Services

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

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX VIDEO CYSTO SCOPE Back to Search Results
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.
 
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Brand NamePENTAX
Type of DeviceVIDEO 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 Key11515805
MDR Text Key240769919
Report Number9610877-2021-00057
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10
Number of Events Reported1
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
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberECY-150S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/18/2021 Patient Sequence Number: 1
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