MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE - I10 STANDARD

Model Number EG29-I10

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  

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 united states stating that "that there was no video error message image" involving pentax video gastroscope model eg29-i10, serial number (b)(4).The customer reported "error 12 to check the scope connection".The timing and location of when the issue was observed were not provided.The customer requested an rma to return the device for evaluation.No death or serious injury were reported.Multiple good faith effort attempt have been made with no additional information being provided.The customer owned endoscope was received by pentax medical for evaluation on 08-sep-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint of image blackout and also documented the following inspection findings: fluid invasion in pve connector, pve electrical pin corroded, ccd circuit board corrosion, up/ down angulation knob play, left light carrying bundle distal cover glass cracked, passed wet leak test, endoscope failed electrical safety test - plct, passed dry leak test, control body mild corrosion inside, pve electrical connector frame mild corrosion, shield cover corroded, core corroded, down angulation decreased, right /left angulation knob play, right angulation decreased.The device underwent repairs including the following components: o-rings and seals, pcb for ccd drive pb-free, electrical connector assy, lcb distal cover glass.The endoscope is awaiting repair and approved by final qc as of 28-sep-2021.Model eg29-i10, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.

Manufacturer Narrative

Correction information: g6: follow up #1, h2: if follow-up, what type? h6: coding changed based on the investigation (health effect - clinical code, health effect - impact code).Additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE - I10 STANDARD
• 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: 12544137
• MDR Text Key: 283256045
• Report Number: 9610877-2021-00993
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• UDI-Public: 04961333211692
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10
• 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: 08/31/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1