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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L
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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L Back to Search Results
Model Number EG-2990I
Medical Device Problem Codes Disconnection (1171); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/13/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to an excessive force applied on the operation channel in the inlet t piece.In addition, we confirmed that the ccd module disconnection, the light guide fiber bundle (lcb) disconnection, and the light guide cable buckle; however, these are not related to the alleged complaint.This report is being filed as part of the pentax backlog management plan.
 
Event or Problem Description
Operation channel buckled at biopsy inlet t-piece.Channel perforated, leaky.This event occurred at the time of reprocessing.There was no report of patient harm.
 
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Brand Name
PENTAX
Common Device Name
HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi, tokyo 196-0 012
JA  196-0012
MDR Report Key12194400
Report Number9610877-2021-10291
Device Sequence Number1480528
Product Code FDS
UDI-Device Identifier04961333248179
UDI-Public04961333248179
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K131902
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberEG-2990I
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/13/2021
Initial Report FDA Received Date07/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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