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 01/21/2021

Event Type  malfunction  

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.

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax video gastroscope eg29-i10c serial: (b)(4).In the event reported, the user stated that there is halo in image, first dots, then screen freezes and now halos.The event timing is unknown.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 not confirmed.The device functioned as intended with no defects found.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.

• 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: 12344849
• MDR Text Key: 283092396
• Report Number: 9610877-2021-00235
• 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: 01/26/2021
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1