MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C

Model Number EG-3670URK

Device Problems Break (1069); No Display/Image (1183)

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

Event Date 08/10/2021

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 video ultrasound scope eg-3670urk.In the event reported, it was stated that the screen is black - no video image.The timing of this anomaly is not known.There was no adverse event reported with this complaint.Pentax medical issued return material authorization (b)(4) for the return of the device for further evaluation.This device is currently pending return to pentax service facility.A review of the service history indicates the device was not routinely serviced at a pentax facility.On 26-aug-2021, a device history record (dhr) review for model eg-3670urk, serial number (b)(4) was performed and the dhr review confirmed the endoscope had 1 non-conformance for rubber loose and no concession.The loose rubber was reworked, and the device completed manufacturing on 05oct2007 under normal conditions, passed all required inspections, and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed.

Manufacturer Narrative

Correction information: g6: follow up #1.H2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information: h4:device manufacture date.Evaluation summary: the sales rep emailed customer service reporting the customer stated the screen is black - no video image.Therefore, we checked the returned unit and confirmed that the ccd module failure.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the us connector body corroded, the us connector cable fluid damage, the lg cable connector scratched, the us connector cable buckled, the remote control buttons failure, the lg cable connector fluid damage, the us connector casing discolored, the insertion flexible tube (ift) crushed, the us probe broken, the suction channel buckled, the remote control buttons failure, the remote control buttons failure, the remote control buttons failure, the light guide cable fluid damage, the bending rubber discolored, the ccd driver pcb corroded, the electrical connector corroded, the insertion flexible tube (ift) crushed, the lcb distal cover glass cracked, the light guide cable buckled, and the lg cable connector corroded; however, they are not the main cause, and/or irrelevant to the alleged complaint.

• Brand Name: PENTAX
• Type of Device: RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C
• 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: 12443059
• MDR Text Key: 283416275
• Report Number: 9610877-2021-00615
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• 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: 10/14/2022

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-3670URK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1