MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L

Model Number	EG-2990I
Medical Device Problem Codes	Leak/Splash (1354); Material Perforation (2205); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to an excessive force on the insertion flexible tube (ift), the force was also applied to the internal operation channel.We received the defect and conducted the following investigation and repair.Observations: operation channel buckled, bending rubber cut, ccd module disconnected, light guide fiber bundle (lcb) disconnected, u/d pulley wire rupture, r/l pulley wire rupture.Repair: operation channel, bending rubber, ccd module, light guide fiber bundle (lcb) , u/d pulley wire, r/l pulley wire.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Operation channel buckled at biopsy inlet t-piece.Channel perforated, leaky.

• 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 Key: 12236988
• Report Number: 9610877-2021-10313
• Device Sequence Number: 3761410
• Product Code: FDS
• UDI-Device Identifier: 04961333248179
• UDI-Public: 04961333248179
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131902
• Number of Events Summarized: 1
• 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): 07/28/2021

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 Number: EG-2990I
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1