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

Model Number EG-3670URK

Device Problems Break (1069); Failure to Disconnect (2541)

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

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the united states within the pai region.The customer reported that a cleaning brush was stuck in the channel involving pentax medical ultrasound video gastroscope model eg-3670urk, serial number (b)(4).The event was observed during reprocessing of the device.There was no report of injury associated with the event, no patient involvement.

Manufacturer Narrative

(b)(4).Multiple good faith effort attempts have been made with no additional details being provided as of 20-dec-2021.The customer owned endoscope was received by pentax medical for evaluation on 07-dec-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint of stuck accessory and documented the following inspection findings: accessory stuck in primary operation channel, passed dry leak test, ultrasound image no scan line, customer complaint confirmed, passed wet leak test, ultrasound image has broken channel.The device will undergo repairs including the following components and be returned to the customer once completed: o-rings and seals, a/w/operation channel, bending rubber, x-ring(1.8x19.6) gray, electrical connector assy.Eg-3670urk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On 06-dec-2021, a device history record(dhr) review for model eg-3670urk, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 05-sep-2017 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 07-sep-2017.Instructions for use(ifu), includes the following warning section 2-1-3, 3) "after using operational/cleaning accessories (e.G., forceps, needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope's instrument/suction channel.Furthermore, ensure that any therapeutic devices (e.G., clips, stents, etc.) passed through the channel are accounted for after use.On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

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.Evaluation summary: customer reported brush stuck/broken in channel.Therefore, we checked the returned unit and confirmed that the operation channel accessory.Based on the result, we concluded that it was caused due to the excessive force applied on the operation channel.In addition, we confirmed that the us probe broken, the us probe failure, and the electrical connector deformed; 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: 13047964
• MDR Text Key: 283769016
• Report Number: 9610877-2021-01703
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333123360
• UDI-Public: 04961333123360
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1