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

Model Number EG-2990I

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

International medical device regulators forum (imdrf) adverse event reporting.(b)(4).Type of investigation: 10 testing of actual/suspected device.The customer responded to a good faith effort request via email on 16-dec-2021 and stated doctor was having problems with the balloon going down and coming up the biopsy channel during the procedure.The procedure was completed with the device and there was no reported injury to the patient or delay.There was also no reported cross contamination risk to the patient and the patient was not recalled for further screenings.The device was removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement.He also confirmed the facility follows all pre-procedureal checks and instructions for use.The customer owned endoscope was received by pentax medical for evaluation on 14-dec-2021.The endoscope was inspected by pentax medical service under service order 3137130 and the technician confirmed the customer complaint and documented the following inspection findings: primary operation channel crimped at biopsy inlet t-piece, passed dry leak test, passed wet leak test, insertion tube mild crush at stage 2, # 2 remote control button cover cracked, umbilical cable single buckled under pve root brace, customer complaint confirmed.The device underwent repairs including the following components: o-rings and seals, operation channel, bending rubber.The endoscope is awaiting repair and approved by final qc as of 07-jan-2022.Model eg-2990i, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.A device history record(dhr) review for model eg-2990i, serial number (b)(4) was previously performed by the manufacturer on 18-oct-2021.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on (b)(6) 2012 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 02-aug-2012.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a complaint which occurred in the united states.The customer stated the there was difficulty getting the balloon up and down the biopsy channel and the cleaning brush will not go down the channel involving pentax medical video gastroscope model eg-2990i, serial number (b)(4).The issue was observed in the operating room during use.There was no report of patient injury or adverse event that necessitated medical intervention.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

Evaluation summary: it was not possible to identify the reason for the clogging.Correction information: h6: coding changed based on the investigation result.

• 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: 13197075
• MDR Text Key: 289887901
• Report Number: 9610877-2022-00008
• 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: 12/08/2022

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: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1