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

Model Number EG29-I10C

Device Problem Erratic or Intermittent Display (1182)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the (b)(6) region involving pentax video gastroscope eg29-i10c serial:(b)(4).In the event reported, the user stated that there is image irregularities including colors/ rolling images.The anomaly was detected before use.No adverse event was reported with this complaint.The device was received at pentax medical service facility for further evaluation on service order (b)(4) where the user narrative was confirmed.Inspection findings is as follows: fluid invasion in pve connector, passed wet leak test, image distorted, air/ water socket cylinder o-ring chipped, fluid invasion not observed in control body, image green.Customer complaint confirmed.The device was repaired where all defects was remediated and returned to the user on delivery # (b)(4).Parts replaced: pcb for driver (cmos), connector frame assy.The root cause of this failure was fluid invasion in the pve connector.

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.There is a similar model available for sale in the united states eg29-i10c-us with a 510k # k190805.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

• 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
• MDR Report Key: 12344756
• MDR Text Key: 280683562
• Report Number: 9610877-2021-00217
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/19/2021

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
• Device Operator: Health Professional
• Device Model Number: EG29-I10C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1