MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L

Model Number EG-2990I

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Event Description

Pentax medical was made aware of a complaint which occurred in the united states within the (b)(4) stating "customer reported no video/error msg, scope not conn.The customer stated it won't connect to processor." involving pentax medical video gastroscope model eg-2990i, serial number (b)(4).There was no report of death, serious injury or other significant/important medical event.The customer owned endoscope was received by pentax medical for evaluation on (b)(6) 2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician was unable to confirm the no video image, but did documented the following inspection findings:distal body chip at channel opening at thinnest part, air/ water nozzle glue missing, passed dry leak test, bending rubber glue cracking at insertion tube side, bending rubber glue cracking at distal side, bending rubber mild discoloration, insertion tube bump at end of root brace, passed wet leak test, light carrying bundle has less than 70% transmission, distal body severe deformed, light carrying bundle broken.Although the user narrative of no video image was not confirmed, additional repairs are being performed for parts that could have contributed to the user experience.The device underwent repairs including the following components: o-rings and seals, bending rubber, distal end assy with tubes, light guide fiber bundle (lcb), adjusting collar, bending rubber, insertion flex tube, angle wire, electrical connector assy, suction channel lg, jet supply tube lg, air/water supply tube lg, light guide column.The endoscope is awaiting repair and approved by final qc as of (b)(6) 2021.Model eg-2990i, serial number (b)(6) has been routinely serviced at a pentax facility since the device was put into service.On (b)(6) 2021, a device history record (dhr) review for model eg-2990i, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the miyagi facility on (b)(6) 2009 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 for (b)(6) 2009.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.

Manufacturer Narrative

(b)(4).Investigation findings: 213 no device problem found.Investigation conclusions: 67 no problem detected.If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: PENTAX
• Type of Device: HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L
• 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: 12526444
• MDR Text Key: 283682518
• Report Number: 9610877-2021-00887
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333129492
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1