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

Model Number EG-2990I

Device Problem No Display/Image (1183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

(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 event which occurred in the pai region involving pentax loaner video scope eg-2990i.In the event reported, it was stated that there was no video image.The event timing is unknown.There was no adverse event reported with this complaint.The loaner device was returned to pentax medical service facility on service order (b)(4) where it's pending further evaluation.A review of the service history indicates the device was not routinely serviced at a pentax facility.On 16-sep-2021, a device history record (dhr) review for model eg-2990i, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 30may2016 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.No other information provided.

Manufacturer Narrative

Evaluation summary: repeated use causes the cable to break off.Correction information g6: follow up #1 h2: type of follow up h6: coding changed based on the investigation result additional information d4: udi.H3: device evaluated.

• 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: 12488293
• MDR Text Key: 283626705
• Report Number: 9610877-2021-00871
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333228478
• UDI-Public: 04961333129492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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: EG-2990I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1