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

Model Number EG16-K10

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

This model is classified as import for export and not distributed in the united states, therefore 510k is not applicable.(b)(4) if additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of an issue that occurred in the operating room, during use, at a facility in (b)(6).The information provided indicated that the air water supply is insufficient at an angle involving pentax medical video gastroscope, model eg16-k10, serial number (b)(4).The investigation is in-process.

Manufacturer Narrative

Evaluation summary: we received a repair request as a pipeline blockage, but we could not confirm the problem of a pipeline blockage.Therefore, the cause of the clogging is unknown.Correction information: g6: follow up #1; h2: type of follow up; h4: device manufacturer date; h6: coding changed based on the investigation result.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• 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: 12451614
• MDR Text Key: 283499597
• Report Number: 9610877-2021-00829
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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
• Device Operator: Health Professional
• Device Model Number: EG16-K10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1