MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA GASTROSCOPE

Model Number	EG29-I10C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Pentax medical was made aware of a complaint which occurred in the emea region during inspection in the workshop with the reporting "the electrical connecting pins on the lg-plug are leaky.Electrical safety test failed." involving pentax medical video gastroscope model eg29-i10c, serial number (b)(4).There was no report of death, serious injury or other significant/important medical event.The defective parts will be replaced as part of the service request.This event is fda reportable due to the lack of information to justify that this event would not cause or contribute to a serious injury or other adverse event.
Additional Manufacturer Narrative
This model is not distributed in the united states, therefore 510k is not applicable.We do have similar model eg29-i10c-us available in the united states with a 510k number k190805.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: PENTAX
• Common Device Name: IMAGINA GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12381165
• Report Number: 9610877-2021-00132
• Device Sequence Number: 4407310
• Product Code: FDS
• UDI-Device Identifier: 04961333248483
• UDI-Public: 04961333248483
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: REFER TO H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2021

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: EG29-I10C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1